chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Condition aggravated, Diagnostic procedure, Drug exposure during pregnancy, Lice infestation
Clinical narrative: Initial and follow-up information has been received from a 16 year old female consumer with head lice and no previous pregnancies, who on 08-APR-2008, was vaccinated with a third dose of GARDASIL vaccine (Lot # 659964/1978U) and later found out that she was pregnant.  Concomitant therapy included DOCUSATE SODIUM + minerals (unspecified) (+) OMEGA-3 marine triglycerides (+) succinic acid (+) vitamins (unspecified) (PRIMACARE)).  At the time of the report the patient was 6 months gestation.  The patient's estimated conception date was approximately 21-NOV-2007, last menstrual period was approximately 30-NOV-2007 and her estimated delivery date was 14-AUG-2008.  The patient sought unspecified medical attention.  Blood work was taken and the results were not reported.  On 24-APR-2008 an ultrasound was performed for an anomaly screening/dating and the results were were within limits.  It was reported that it was too late to perform a Maternal Serum Alpha-Fetoprotein Screening (MSAFF).  At the time of the report, the outcome of the patient was unknown.  Additional information was received from the physician's office stating that the patient delivered a normal infant without congenital anomalies.  Additional information was received from a registered nurse concerning the patient who on 14-AUG-2008 (weeks from LMP: 40+) delivered a female normal infant without congenital abnormalities and complications or abnormalities.  The infant weight: 7#  7 oz.  length: 21".  "Apgar scores: 8/10, and 9/10", head circumference : 34cm.  It was reported that the patient presented late entrant to care at 25 weeks.  In May 2008, the patient was diagnosed with with head lice.  In "mid-May" 2008, the patient was treated with RID.  The patient experienced maternal fever during labor/delivery.  The patient was GBS (+) and was treated with antibiotics in labor.  Additional information has been requested. 04/07/09 This is in follow-up to report(s) previously submitted on 11/14/2008. Additional information has been received from the nurse who informed that the patient's baby had "no problems" and was healthy and normal. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Streptococcal identification test positive, Ultrasound scan abnormal
Clinical narrative: Initial and follow-up information has been received from a 16 year old female consumer with head lice and no previous pregnancies, who on 08-APR-2008, was vaccinated with a third dose of GARDASIL vaccine (Lot # 659964/1978U) and later found out that she was pregnant.  Concomitant therapy included DOCUSATE SODIUM + minerals (unspecified) (+) OMEGA-3 marine triglycerides (+) succinic acid (+) vitamins (unspecified) (PRIMACARE)).  At the time of the report the patient was 6 months gestation.  The patient's estimated conception date was approximately 21-NOV-2007, last menstrual period was approximately 30-NOV-2007 and her estimated delivery date was 14-AUG-2008.  The patient sought unspecified medical attention.  Blood work was taken and the results were not reported.  On 24-APR-2008 an ultrasound was performed for an anomaly screening/dating and the results were were within limits.  It was reported that it was too late to perform a Maternal Serum Alpha-Fetoprotein Screening (MSAFF).  At the time of the report, the outcome of the patient was unknown.  Additional information was received from the physician's office stating that the patient delivered a normal infant without congenital anomalies.  Additional information was received from a registered nurse concerning the patient who on 14-AUG-2008 (weeks from LMP: 40+) delivered a female normal infant without congenital abnormalities and complications or abnormalities.  The infant weight: 7#  7 oz.  length: 21".  "Apgar scores: 8/10, and 9/10", head circumference : 34cm.  It was reported that the patient presented late entrant to care at 25 weeks.  In May 2008, the patient was diagnosed with with head lice.  In "mid-May" 2008, the patient was treated with RID.  The patient experienced maternal fever during labor/delivery.  The patient was GBS (+) and was treated with antibiotics in labor.  Additional information has been requested. 04/07/09 This is in follow-up to report(s) previously submitted on 11/14/2008. Additional information has been received from the nurse who informed that the patient's baby had "no problems" and was healthy and normal. No further information is available.
Age: 16.0
Sex: F
Vaccine: HIBV, HPV4
Symptoms: Anaemia, Drug exposure during pregnancy, Rhesus antibodies negative, Ultrasound scan normal
Clinical narrative: Information has been received from a health professional for pregnancy registry for GARDASIL concerning a 16 year old female with no relevant medical history who on 27-JUN-2007 and 24-APR-2008 was vaccinated with a first and second dose of GARDASIL intramuscular injection (lot number and injection site not reported). She also received her first dose of PEDVAXHIB (MSD) on 27-JUN-2007, the second dose on 27-2007, and third dose on 27-MAR-2008. There was no concomitant medication. Then it was discovered that she was pregnant. No adverse effects reported. The patient had her first prenatal care visit this week and an ultrasound was scheduled for 26-JUN-2008. Follow up information was from a registered nurse reported that the patient had no previous pregnancies history. On 26-JUN-2008 ultrasound (checks fetal development late prenatal care) was performed and result was within normal limits. The patient's LMP=14 FEB-2008 and the estimated delivery date = 20-NOV-2008. Follow up information was received from a registered nurse (R.N.) who reported that during this pregnancy, the patient was on placed on ferrous sulfate for the treatment of anemia, globulin, immune (RHOGAM) for treatment of rhesus antibodies negative and prenatal vitamins as supplementation. On 25-JUN-2008 the patient underwent ultrasound. The patient was late in receiving prenatal care (30 weeks). On 23-JUL-2008, 39 weeks from LMP, the patient delivered a normal female baby whose weight was 6 pound and 6 ounce, length 19 inches, head circumference 13.5 inches and Apgar score 9/9. There were no congenital anomalies or other complications or abnormalities. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a registered nurse concerning a 15 year old female with no pertinent medical history and no drug reactions/allergies, who on 14-JAN-2008 was vaccinated with the first dose of GARDASIL 0.5 mL, IM. On 26-MAR-2008, the patient received the second dose of GARDASIL 0.5 mL, IM. There was no concomitant therapy. The patient is pregnant (positive pregnancy test). At the time of report, the patient was 31 weeks gestation (last menstrual period approximately 20-DEC-2007, estimated delivery date 25-SEP-2008). The patient did not seek medical attention. No other symptoms were noted. Follow-up information was received from the nurse who reported that the patient had a history of asthma and positive PPD. The nurse reported that the patient delivered a normal healthy female baby on 19-SEP-2008 with no congenital anomalies and there were no other complications. The Baby weighed 2810 grams, and APGAR score was 9/9. There were no birth defects and no complications with the infant. There were no infections or illness during the pregnancy. The nurse reported that during the pregnancy on 18-JUL-2008, the patient's ultrasound test resulted normal for fetal anatomy. During the pregnancy, the patient took prenatal vitamins for pregnancy and ferrous sulfate for anemia. The patient had not had any previous pregnancies. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Pregnancy, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a physician and a medical assistant for the pregnancy registry for GARDASIL concerning a 19 year old female with no drug reactions or allergies and with a history of papanicolaou smear abnormal and vaginosis bacterial, who on 15-SEP-2008, was seen in the office for symptoms of painful vaginal discharge. During her appointment she was vaccinated with her first dose of GARDASIL (lot#661046/0381x), 0.5 ml, IM. On the same date, she was placed on therapy with amoxicillin 500 mg, three times a day, for urinary tract infection. It was later found prenatal forte. On 22-SEP-2008, ultrasound was performed and results were normal with comments that estimated delivery date was 03-APR-2009 and the patient had been pregnant for 12 weeks and 3 days. The patient sought medical attention in the office. Additional information is not expected. Follow-up information was received from a pediatrician via Pregnancy Questionnaire for GARDASIL. On 25-JUL-2008 the patient was treated 7 days with metronidazole 500 mg twice a day for bacterial vaginosis. On 15-SEP-2008 the patient was treated with AMOXICILLIN 500 mg three times a day for urinary tract infection. On 15-SEP-2008 the patient was vaccinated with GARDASIL (lot # 661046/0381K) and started prenatal Forte tablet one daily. It was noted the patient had no previous pregnancies and date of LMP was unknown. Infections or illnesses during pregnancy inlcuded +group B strep vaginal culture and + bacterial vaginosis. On 01-OCT-2008 the patient was treated for 7 days with metronidazole 500 mg twice a day for bacterial vaginosis. There was no complication during pregnancy. Diagnostic test during pregnancy also included ultrasound for fetal survey with normal results on 21-JAN-2009 and ultrasound for biophysical profile with normal results on 06-APR-2009. On 10-APR-2009 the patient had a low tranverse C-section due to failure to progress and delivered a normal female baby with no congenital anomalies, weight 8 lbs and 4 ozs, length 21 inches. Apgar score 9/9 and head circumference 13 3/4 inches. It was reported that the baby has failed right ear on hearing screen test and the test would be repeated at two months of age. Upon internal review, C-section due to failure to progress was determined to be an other important medical event. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection, Vaginal discharge
Clinical narrative: Initial and follow-up information has been received from a physician and a medical assistant for the pregnancy registry for GARDASIL concerning a 19 year old female with no drug reactions or allergies and with a history of papanicolaou smear abnormal and vaginosis bacterial, who on 15-SEP-2008, was seen in the office for symptoms of painful vaginal discharge. During her appointment she was vaccinated with her first dose of GARDASIL (lot#661046/0381x), 0.5 ml, IM. On the same date, she was placed on therapy with amoxicillin 500 mg, three times a day, for urinary tract infection. It was later found prenatal forte. On 22-SEP-2008, ultrasound was performed and results were normal with comments that estimated delivery date was 03-APR-2009 and the patient had been pregnant for 12 weeks and 3 days. The patient sought medical attention in the office. Additional information is not expected. Follow-up information was received from a pediatrician via Pregnancy Questionnaire for GARDASIL. On 25-JUL-2008 the patient was treated 7 days with metronidazole 500 mg twice a day for bacterial vaginosis. On 15-SEP-2008 the patient was treated with AMOXICILLIN 500 mg three times a day for urinary tract infection. On 15-SEP-2008 the patient was vaccinated with GARDASIL (lot # 661046/0381K) and started prenatal Forte tablet one daily. It was noted the patient had no previous pregnancies and date of LMP was unknown. Infections or illnesses during pregnancy inlcuded +group B strep vaginal culture and + bacterial vaginosis. On 01-OCT-2008 the patient was treated for 7 days with metronidazole 500 mg twice a day for bacterial vaginosis. There was no complication during pregnancy. Diagnostic test during pregnancy also included ultrasound for fetal survey with normal results on 21-JAN-2009 and ultrasound for biophysical profile with normal results on 06-APR-2009. On 10-APR-2009 the patient had a low tranverse C-section due to failure to progress and delivered a normal female baby with no congenital anomalies, weight 8 lbs and 4 ozs, length 21 inches. Apgar score 9/9 and head circumference 13 3/4 inches. It was reported that the baby has failed right ear on hearing screen test and the test would be repeated at two months of age. Upon internal review, C-section due to failure to progress was determined to be an other important medical event. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from an office manager concerning a female who on approximately 17-SEP-2008 was vaccinated intramuscularly with a first dose of GARDASIL vaccine (yeast).  The office manager reported that the patient fainted after receiving vaccination.  At the time of reporting, the outcome was unknown.  It was not specified if the patient sought medical attention or not.  Follow-up information was received from a registered nurse who reported that the patient fainted after receiving the first dose of GARDASIL vaccine (yeast) with immediate recovery.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse, mother of the patient, concerning here daughter, who on approximately 30-SEP-2007, was vaccinated with her first dose of GARDASIL. Upon administration the patient experienced pain and swelling at injection site. The swelling lasted approximately 2.5 weeks. No medical intervention was necessary. The patient recovered fully and did receive the second and third dose of GARDASIL with no other adverse experiences. Additional information has bee requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a nurse concerning a 12 year old female with drug hypersensitivity who on 10-Jul-2008 was vaccinated IM with her first dose of GARDASLI and her second dose of VARIVAX and on 30-Sep- 2008 was her second dose of GARDASIL since receiving the first dose of GARDASIL. She has had a variation of menstrual cycle. Her first menstrual period after the first dose of GARDASIL lasted 8 days. She then had a 2 menstrual periods 20 days apart. She has had a regular cycle for one year prior to receiving her first dose of GARDASIL. At the time of reporting, the patient was not recovered. No additional information at this time. The medical attention was sought in office, Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female patient with allergy to penicillin. Who on 30-Sep-2008 received a dose of GARDASIL, ( route and injection site not reported). On an unknown date after vaccination, she developed tiredness, headache, and tingling in her ankles. The patient sought medical attention via phone call to office. At the time of reporting she had not recovered from the events. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain in extremity, Stomach discomfort
Clinical narrative: Information has been received from a consumer concerning her sister, a 16-year-old female, who on 21-AUG-2008 received a first dose of GARDASIL in her left arm.  On 28-AUG-2008, a week later, the patient started to have pain in the back of her knee.  Then not to long after that she started to have a dull aching pain in her upper right arm, in the triceps area, but was not sure if it was coming from her elbow or shoulder, and at times she would have a sharp pain in triceps as well.  The patient has seen her primary care physician about the pain she was having and was treated with naproxen, which gave her stomach problems and so she stopped taking it.  The patient's primary care physician did blood work for her on 30-SEP-2008.  She will have an ultra sound check on 06-OCT-2008 on her arm and leg.  At the time of reporting, the results of her blood test were unknown and the patient's symptoms persisted.  Additional information has been requested.  12/15/08 Received PCP medical records. FINAL DX: bursitis/synovitis, gen arthrosis,  Records reveal patient expereienced GERD & left knee pain x 3 weeks on 9/16 visit.  Tx w/meds.  RTC 9/29 w/right arm/shoulder pain & decreased ROM, knee pain had improved.  Meds adjusted & labs ordered.  RTC 10/8 w/arm & knee pain.  Injected knee, changed meds & x-ray/MRI ordered.   2/25/09 Received GYN vaccine records & medical records of 10/19/06-2/12/2009. FINAL DX:none provided. Records reveal patient received only HPV #1 on 8/21/08.  RTC for annual exams w/o complaints.  On 2/12/09 c/o of muscle aches s/p HPV & no further shots given.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Gait disturbance, Pain, Pelvic pain
Clinical narrative: Information has been received from a nurse reported that her niece, a 17 white female, on 08-OCT-2007 was vaccinated with the first dose of GADASIL (lot # 658556/1060U) into her right deltoid.  After vaccination, the patient experienced stomach cramps and extreme pelvic pain as "if her guts were going to fall out".  The patient said that it hurt to walk, move and sit down, she had to lie down.  Everything she took did not ease the symptoms.  Unspecified medical attention was sought.  Subsequently, the patient recovered from stomach cramps.  The patient said she was not the only one to experience these symptoms, the whole cheerleading squad (total number of girls was not specified) also experienced the symptoms after receiving the first dose of GARDASIL vaccine.  In follow up the patient was reported to have taken an unspecified medication to ease the pain, which did not work.  She had recovered from all symptoms and will not receive other shots.  This is one of the several reports received from the same source.  No further information is available.  4/2/09 Received only med record of 10/8/2007 which reveals patient had cough & congestions x few days & dx w/recurrent bronchitis.  Tx w/oral antibiotics & received  hep A, HPV & flu vaccines.  No additional med records available & no additional lot #s available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who on unknown dates was vaccinated with all three doses of GARDASIL. On an unspecified date, the patient on a pap smear tested positive for HPV. The patient's previous pap smears prior to vaccination with GARDASIL were negative for HPV. Unspecified medical attention was south. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a teenager female who on an unspecified date was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Subsequently the patient experienced dizzy for a week. It was worst in the mornings. The patient decided not to complete the series. Subsequently, the patient recovered from dizzy. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation
Clinical narrative: Information has been received from a pharmacist concerning several female patients experienced burning sensations while receiving GARDASIL with lot number 660620/0571X. No further information is available. The patients were seen by a nurse.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Condition aggravated
Clinical narrative: Information has been received from a physician concerning a female with one genital wart before vaccination who was vaccinated with a dose of GARDASIL.  Subsequently the patient developed a whole colony of genital warts.  The patient's outcome was unknown.  The patient sought medical attention in the physician's office.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Pruritus, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 22 year old female, who 25-SEP-2008, was vaccinated with the second dose of GARDASIL, IM. Concomitant therapy included "birth control". "About a week post vaccination", the patient experienced swelling at the injection site, and two itchy hive like bumps on her opposite-side arm and leg. Physician reported that he recommended diphenhydramine HCL (BENADRYL) to treat the symptoms. No lot number was reported. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Computerised tomogram normal, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from the physician's assistant concerning a college aged female who an unspecified date who vaccinated with the first dose GARDASIL.  After receiving her first dose. The patient developed headaches. The patient sought medical attention, office visit. On an unspecified date,a magnetic resonance imaging(MRI), a computed tomography (CT) scan of head and blood test were performed.  All test and studies were within normal limits. At the time of reporting, the patient had not recovered. Additional information has been requested. Follow up information was received from the patient's pediatrician's office manager concerning the dates at which the 17 year old female received the three doses of GARDASIL. The first dose was administered on 30-MAY-2007, the second dose of GARDASIL was received on 09-AUG-2007 and the third dose of GARDASIL was adminstered on 26-DEC-2007. On 24-MAR-2008 the patient was seen at the office for complaints of headaches but was never hosiptalized. The patient felt the headaches were related to the GARDASIL, but was not the opinion of the medical assistant. As of 23-DEC-2008, the patient was still complaining of chronic headaches. Additional information is not expected.  1/14/09 Reviewed Neuro medical records of 3/24-8/25/2008. FINAL DX: chronic migraine HA; chronic neck pain. Records reveal patient experienced chronic HA x 1 year w/phonophobia, photophobia, dizziness, fatigue, visual lights flashing/bright spots, blurry vision, neck pain.  Had 2 episodes of numbness & tinling of toes/fingers w/hot flashes.  Tx w/multiple med trials & PT w/some improvement.  Seen in Er 8/08 for intense HA & tx w/flexeril & chiropractor which relieved HA.  HA, nausea & blurred vision returned when flexeril d/c.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 18-SEP-2008 was vaccinated with a dose of GARDASIL. Two days after vaccination, on 20-SEP-2008, the patient had a rash. The reporter stated that the patients rash appeared from the upper arm to the shoulder. The rash lasted for two days. The patient sought medical attention and contacted the nurse practitioner. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient with a family history of migraines and no known allergies, who on 13-AUG-2008 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot# 658490/0802U).  On 18-SEP-2008, the patient received the second 0.5 ml IM dose of GARDASIL (lot# 659964/1978U).  There was no concomitant medication.  On 18-SEP-2008 the patient experienced intermittent severe headaches after administration of her second dose.  No lab diagnostics studies was performed.  At the time of this report, the adverse event was ongoing.  The patient sought medical attention via telephone.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Abdominal pain, Abdominal pain upper, Appendicitis, Back pain, Colonoscopy normal
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter with oesophageal acid reflux who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine along with varicella virus vaccine live (Oka/Merck) (MSD).  Concomitant therapy included (PREVACID).  On the week before second dose, the patient experienced cold symptoms and strep throat.  On 26-AUG-2008, the patient got a strep throat test, and the outcome of strep throat test was negative.  So, on 26-AUG-2008 the patient was vaccinated with the second dose of GARDASIL vaccine.  On 08-SEP-2008, the patient was taken to the ER with signs of appendicitis.  Since then, she took the CT scans, bloodwork, endoscopy, colonoscopy, and X-rays, and the outcome of those tests turned out normal, but her condition is getting worse.  On 09-SEP-2008, the patient developed rash on her belly and left eye.  The patient experienced stomach pain, abdominal pain, back pain, headaches, dizziness. It hurts the patient to lift her arms above her head, cross her legs due to pain during sleep.  The patient was given DICYCLOMINE (manufacturer unspecified) "in case she had irritable bowel", but this therapy resulted in dizziness.  Patient's adverse events persisted.  The patient sought medical attention in the ER.  Additional information has been requested. 12/11/08 Received PCP medical records.  FINAL DX: none provided Records consist of Neuro consult done 10/28/08 for HA, dizziness & abdominal pain which started approx 10 days after HPV#2.  Had gone to ER for abd pain on 9/8/08, w/u WNL.  9/19 RTC w/bilateral serous OM. 12/12 RTC w/pharyngitis.  GI consult for endoscopy, colonoscopy, CT & US.  Had psych eval which was WNL.  Ophtho eval.  No further records available.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Computerised tomogram normal, Dizziness, Dyskinesia, Endoscopy normal, Headache
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter with oesophageal acid reflux who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine along with varicella virus vaccine live (Oka/Merck) (MSD).  Concomitant therapy included (PREVACID).  On the week before second dose, the patient experienced cold symptoms and strep throat.  On 26-AUG-2008, the patient got a strep throat test, and the outcome of strep throat test was negative.  So, on 26-AUG-2008 the patient was vaccinated with the second dose of GARDASIL vaccine.  On 08-SEP-2008, the patient was taken to the ER with signs of appendicitis.  Since then, she took the CT scans, bloodwork, endoscopy, colonoscopy, and X-rays, and the outcome of those tests turned out normal, but her condition is getting worse.  On 09-SEP-2008, the patient developed rash on her belly and left eye.  The patient experienced stomach pain, abdominal pain, back pain, headaches, dizziness. It hurts the patient to lift her arms above her head, cross her legs due to pain during sleep.  The patient was given DICYCLOMINE (manufacturer unspecified) "in case she had irritable bowel", but this therapy resulted in dizziness.  Patient's adverse events persisted.  The patient sought medical attention in the ER.  Additional information has been requested. 12/11/08 Received PCP medical records.  FINAL DX: none provided Records consist of Neuro consult done 10/28/08 for HA, dizziness & abdominal pain which started approx 10 days after HPV#2.  Had gone to ER for abd pain on 9/8/08, w/u WNL.  9/19 RTC w/bilateral serous OM. 12/12 RTC w/pharyngitis.  GI consult for endoscopy, colonoscopy, CT & US.  Had psych eval which was WNL.  Ophtho eval.  No further records available.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Irritable bowel syndrome, Nasopharyngitis, Pharyngitis streptococcal, Rash, Streptococcal identification test negative
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter with oesophageal acid reflux who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine along with varicella virus vaccine live (Oka/Merck) (MSD).  Concomitant therapy included (PREVACID).  On the week before second dose, the patient experienced cold symptoms and strep throat.  On 26-AUG-2008, the patient got a strep throat test, and the outcome of strep throat test was negative.  So, on 26-AUG-2008 the patient was vaccinated with the second dose of GARDASIL vaccine.  On 08-SEP-2008, the patient was taken to the ER with signs of appendicitis.  Since then, she took the CT scans, bloodwork, endoscopy, colonoscopy, and X-rays, and the outcome of those tests turned out normal, but her condition is getting worse.  On 09-SEP-2008, the patient developed rash on her belly and left eye.  The patient experienced stomach pain, abdominal pain, back pain, headaches, dizziness. It hurts the patient to lift her arms above her head, cross her legs due to pain during sleep.  The patient was given DICYCLOMINE (manufacturer unspecified) "in case she had irritable bowel", but this therapy resulted in dizziness.  Patient's adverse events persisted.  The patient sought medical attention in the ER.  Additional information has been requested. 12/11/08 Received PCP medical records.  FINAL DX: none provided Records consist of Neuro consult done 10/28/08 for HA, dizziness & abdominal pain which started approx 10 days after HPV#2.  Had gone to ER for abd pain on 9/8/08, w/u WNL.  9/19 RTC w/bilateral serous OM. 12/12 RTC w/pharyngitis.  GI consult for endoscopy, colonoscopy, CT & US.  Had psych eval which was WNL.  Ophtho eval.  No further records available.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: X-ray normal
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter with oesophageal acid reflux who on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine along with varicella virus vaccine live (Oka/Merck) (MSD).  Concomitant therapy included (PREVACID).  On the week before second dose, the patient experienced cold symptoms and strep throat.  On 26-AUG-2008, the patient got a strep throat test, and the outcome of strep throat test was negative.  So, on 26-AUG-2008 the patient was vaccinated with the second dose of GARDASIL vaccine.  On 08-SEP-2008, the patient was taken to the ER with signs of appendicitis.  Since then, she took the CT scans, bloodwork, endoscopy, colonoscopy, and X-rays, and the outcome of those tests turned out normal, but her condition is getting worse.  On 09-SEP-2008, the patient developed rash on her belly and left eye.  The patient experienced stomach pain, abdominal pain, back pain, headaches, dizziness. It hurts the patient to lift her arms above her head, cross her legs due to pain during sleep.  The patient was given DICYCLOMINE (manufacturer unspecified) "in case she had irritable bowel", but this therapy resulted in dizziness.  Patient's adverse events persisted.  The patient sought medical attention in the ER.  Additional information has been requested. 12/11/08 Received PCP medical records.  FINAL DX: none provided Records consist of Neuro consult done 10/28/08 for HA, dizziness & abdominal pain which started approx 10 days after HPV#2.  Had gone to ER for abd pain on 9/8/08, w/u WNL.  9/19 RTC w/bilateral serous OM. 12/12 RTC w/pharyngitis.  GI consult for endoscopy, colonoscopy, CT & US.  Had psych eval which was WNL.  Ophtho eval.  No further records available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no drug reactions/allergies who no pertinent on 18-SEP-2008, was vaccinated IM with the third dose of GARDASIL 0.5 ml (lot#0573X). There was no concomitant medication. Shortly after her third dose, the patient developed pain at the injection site.  The patient's pain at the injection site persisted. No lab or diagnostic studied were performed. It was reported that the patient sought medical attention: office visit. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a nurse concerning a 24 year old female, who on 05-MAR-2008, was administered her first dose of GARDASIL. Subsequently, the patient experienced hair loss "since she was given the first dose of " GARDASIL.  The patient was administered second dose of GARDASIL on 06-MAY-2008, and third dose on 08-SEP-2008. The patient's hair loss persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 29-JUL-2008 was vaccinated with the first dose of GARDASIL (lot n. 660389/1668U) 0.5 mL intramuscularly. On 26-SEP-2008. On 26-SEP-2008, the patient was vaccinated with a second dose of GARDASIL (Lot n. unspecified). There was no concomitant medication. Nurse practitioner reported that after dose 1 of GARDASIL, the patient hasn't had any periods. The patient has been diagnosed with amenorrhea. The patient saught unspecified medical attention. The patient's last normal cycle was on 16-JUL-2008. At time of reporting the patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a nurse concerning a 21 year old female, who "several months ago" , was vaccinated with the first dose of GARDASIL, and was fine in the office. When she got home, developed flu-like symptoms. The patient did received a second dose of GARDASIL and was fine. It was unknown if the patient sought medial attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from an office manager concerning a female who on an unspecified date was vaccinated intramuscularly with a first dose of GARDASIL. The office manager reported that patient fainted after receiving vaccination. At the time time of reporting, the outcome was unknown. It was not specified if the patient sought medical attention or not. Follow-up information was received from a registered nurse who reported that the patient fainted after receiving the first dose of GARDASIL with immediate recovery. This is one of several reports received from the same source. Additional information has been requested
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Pruritus, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning her daughter, a 11 year old female with a history of ventricular septal defect (discovered in 2002), who on 31-JUL-2008, was vaccinated with the first dose of GARDASIL, lot # 660553/0070X, 0.5 ml, intramuscularly in her left arm. Concomitant therapy included MENACTRA. It was reported that following the first vaccination with GARDASIL, the patient developed a rash on the injection site, arm. The rash was described as papular, mildly itchy from the elbow to the shoulder. The onset of the rash was unknown at the time of the report. The rash was reported to have "lasted a while", but no time frame was available. On an unspecified date, the patient recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Dizziness, Full blood count normal, Physical examination normal
Clinical narrative: Information has been received from a nurse concerning a 20 year old female with drug hypersensitivity to sulfamethoxazole and trimethoprim (BACTRIM), sulfamethoxazole (+) trimethoprim (SEPTRA), and Amoxicillin Clavulanate (AUGMENTIN) with costochondritis (for past year), who on 07-APR-2008, was vaccinated with her first dose of GARDASIL (lot# 659964/1978U), 0.5 ml, intramuscularly. On 09-JUN-2008, the patient received her second dose of GARDASIL (lot#60553/0070X). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). Subsequently, in 2008, days or weeks, after receiving the second dose, the patient experienced intermittent dizziness. There is an orthostatic component to the dizziness, but not always. She was seen by her doctor and a complete blood count, her blood pressure and her ears were all within normal limits. The patient's doctor cleared her for receiving the third dose. The third dose may possibly be given on 03-OCT-2008. The patient's intermittent dizziness persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL. The physician reported that a month after the patient received GARDASIL, she still had pain at the injection site. No treatment required. At the time of the report, the patient had recovered. The patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 30-Sep-2008 was vaccinated with the first dose of GARDASIL (Lot # 660618/0572X). Concomitant therapy included ethinyl estradiol/norgestimate (ORTO TRI-CYCLEN LO). On 03-OCT-2008, the patient experienced hives on her chest, arms, back and shoulders after receiving the first dose of GARDASIL. The patient's outcome was not reported. The patient sought medical attention by a phone call. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dos of GARDASIL, and subsequently was being treated for generalized body pain and muscle spasms. The patient was not recovered. The patient sought medical attention by an office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Depression
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a dose of GARDASIL injection, and subsequently experienced a strong feeling of depression. The patient's outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a physician and a consumer concerning her 19 year old daughter with no previous medical history and allergies reported, who on 01-OCT-2008 a nurse practitioner inadvertently gave another dose of GARDASIL. The patient experienced injection site pain after received the fourth dose of GARDASIL . The patient had completed a series during the summer. Concomitant therapy included meningitis vaccine (manufacturer unspecified) and TB shot (manufacturer unspecified). The patient did not seek medical attention. The patient did not have illness at time of vaccination. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Information has been received from a certified nurse practitioner concerning a 25 year old female patient with no previous medical history and no known drug allergies reported, who on 15-AUG-2008, was vaccinated with a dose of GARDASIL (Lot # 0530U) IM, 0.5 mL in the left deltoid. A couple days after vaccination, in August 2008 the patient developed severs arm pain. On 25-AUG-2008, the patient called to reported that she experienced a persistent injection site soreness. On 26-AUG-2008, the patient was seen by her family physician and the site was, without redness and warmth. The patient was referred to an orthopedist who referred her to physical therapist. She had physical therapy for four weeks but continued to have arm pain, the physical therapy was completed; and was treated with anti inflammatory. In October 2008, a magnetic resonance imaging was performed, which result showed negative for tearing. The patient had been taking oral antiinflammatories (NAPROXEN) for her symptoms and had recheck for two months. At the time of the reporting the patient was recovering. The patient did not had illness at time of vaccination. The persistent injection site soreness was considered to be disability by the physician. Follow up information has been received from the certified nurse practitioner, who stated that the patient had followed up with an orthopedic physician and she confirmed that the patient was never hospitalized. The nurse also reported that the patient reported that "everyday after the injection, the injection site pain became more painful." Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cryotherapy, Skin papilloma
Clinical narrative: Information has been received from a consumer concerning here 17 year old daughter with unspecified allergies and no known drug reactions, who between November and December 2007, was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The patient developed numerous wart-like lesions on the fingers of both hands in December 2007. The patient was treated with cryotherapy as well as an unspecified topical cream by an unspecified dermatologist near her college. The warts improved, but recurred when the topical therapy was discontinued. The patient received the second dose of GARDASIL on an unspecified date and her third dose in August 2008. The patient sought medical attention by an office visit. There were no lab diagnostics studies performed. At time of reporting, the patient had not recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Antinuclear antibody negative, Blood thyroid stimulating hormone, Condition aggravated, Headache
Clinical narrative: Information has been received from a physician via lawyer concerning a 16 year old female student with no known drug allergies a family history of thyroid disease and a history of headache who on 26-MAR-2007 was vaccinated with the first dose of GARDASIL IM into her left deltoid. On 29-MAY-2007, the patient received the second GARDASIL. On 01-OCT-2007, the patient received the third dose of GARDASIL IM into her left deltoid. There were no illness at the time of vaccination. In June 2008, the patient experienced bitemporal headache with phonophobia and photophobia lasting 24 hrs every 2-3 days. The patient was treated with TOPAMAX for the headache. In July 2008, the patient experienced sudden hair loss. Lab tests included a serum antinuclear antibodies test (ANA) serum thyroid-stimulating hormone test (TSH) and erythrocyte sedimentation rate (RSR) with normal results. Additional information is not expected.  12/31/08 Reviewed PCP medical records. FINAL DX: alopecia, HA Records reveal that on 11/27/08 office visit patient experienced sudden severe alopecia x 1 week, HA w/nausea, photo/phonophobia intermittently x 1 mo.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Phonophobia, Photophobia, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician via lawyer concerning a 16 year old female student with no known drug allergies a family history of thyroid disease and a history of headache who on 26-MAR-2007 was vaccinated with the first dose of GARDASIL IM into her left deltoid. On 29-MAY-2007, the patient received the second GARDASIL. On 01-OCT-2007, the patient received the third dose of GARDASIL IM into her left deltoid. There were no illness at the time of vaccination. In June 2008, the patient experienced bitemporal headache with phonophobia and photophobia lasting 24 hrs every 2-3 days. The patient was treated with TOPAMAX for the headache. In July 2008, the patient experienced sudden hair loss. Lab tests included a serum antinuclear antibodies test (ANA) serum thyroid-stimulating hormone test (TSH) and erythrocyte sedimentation rate (RSR) with normal results. Additional information is not expected.  12/31/08 Reviewed PCP medical records. FINAL DX: alopecia, HA Records reveal that on 11/27/08 office visit patient experienced sudden severe alopecia x 1 week, HA w/nausea, photo/phonophobia intermittently x 1 mo.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician assistant concerning a female who was vaccinated with GARDASIL 0.5ml. Subsequently the patient experienced rash down her arm. On an unknown date, the patient recovered from rash down her arm. The patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no pertinent medical history, allergies or drug reactions, who on 02-Oct-2008 was vaccinated with the first dose of GARDASIL (lot no. 660618/0572X). The patient was concomitantly vaccinated with a dose of VAQTA (manufacturer unknown). On 02-Oct-2008, the patient experienced syncope/fainting. The office called Emergency Medical Services, and they administered oxygen to her. The physician reported that the patient was fine when EMS arrived. Subsequently, the patient recovered. The physician felt that the patient's syncope was an another important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 20 year old female who was vaccinated with GARDASIL. Subsequently the patient experienced rash. The outcome of the patient was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Pelvic pain
Clinical narrative: Information has been received from a nurse who reported that her niece's whole cheerleading squad experienced stomach cramps and/or pelvic pain after receiving the first dose of GARDASIL. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with no medical history or drug allergies, who on 05-SEP-2008, was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot#:660612/0229X).Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). It was reported that the patient experienced fever, nausea and vomiting within a couple of hours of getting home from her appointment. She had no localized reactions. Her symptoms lasted for 48 hours. The patient recovered from fever, nausea and vomiting. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pain in extremity
Clinical narrative: Information has been received from a nurse for the pregnancy registry for GARDASIL vaccine concerning a female who on 12-May-2008 was vaccinated IM with the first dose of GARDASIL (lot no. unknown). On 01-Oct-2008 she was vaccinated IM with the second dose of GARDASIL (lot no. 359182/1757U). The patient found out on 05-Oct-2008 that she was pregnant. the patient has also experienced soreness of her arm after the second dose of the vaccine. Additional information has been requested.