chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with all three doses of GARDASIL (lot# not provided). Subsequently the patient had abnormal Papanicolaou test after the vaccination. The patient sought unspecified medical attention. The patient had colposcopy performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Pain, Viral infection, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 13 year old granddaughter with no known pertinent medical history who in August 2007, was vaccinated IM with the first dose of GARDASIL. In February 2008 the patient was vaccinated IM with the third dose of GARDASIL. There was no lot number reported. There was no concomitant medication. In March 2008, the patient 'started getting pain in her side 3-4 inches below her waistline whenever she would stand for a period of time or exercise'. Unspecified medical attention was sought. Bloodwork and CT scan were performed (results not reported). On 26-JAN-2010 the patient threw up violently and her side hurt when this happened. Her doctor said that she threw up because of a virus. At the time of the report, the patient's pain in her side persisted. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Coagulopathy, Dizziness, Influenza like illness, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her daughter with no known drug reactions/allergies and medical history reported who on an unspecified dates was vaccinated with the first, second and third doses of GARDASIL. The reporter stated that on unspecified dates, her daughter experienced dizziness, flu-like symptoms, 102 degree fever and is having problems with clotting after receiving GARDASIL. These adverse experiences happened after every dose of GARDASIL. It was unknown if the patient sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Foetal disorder, Pregnancy test urine positive, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient with penicillin allergy and a history of preeclampsia in 2007 pregnancy and one full term delivery at 37 weeks gestation who on 21-OCT-2008, 12-FEB-2009 and 20-JUL-2009 was vaccinated IM with the first (lot# 661764/0650X), second (lot# 661952/1129X) and third (662300/0100Y) 0.5ml doses of GARDASIL respectively. On 14-AUG-2009, a urine pregnancy test was performed and the patient was determined to be pregnant. No problems reported. An ultrasound was performed for dating on 25-AUG-2009 and it showed pregnancy at 6 weeks and 5 days gestation. A maternal serum Alpha-Fetoprotein Screening was performed on 02-NOV-2009, and the result was within normal limits (WNL). The patient's last menstrual period was 20-JUN-2009. Expected date of delivery was 27-MAR-2010. Follow up information from a register nurse indicated that on 23-NOV-2009, an ultrasound was performed and showed echogenic focus left ventricle. On 30-NOV-2009, a level II ultrasound was performed and the result was not provided. On 09-APR-2010 (39 weeks from LMP), the patient delivered a normal male baby (6 lb 8 oz, 20 in length, head circumference 32 and APGAR score 9 at 1 minute/9 at 5 minutes). At the time of the report, the patient's status was unknown. The mother's experience has been captured in WAES# 0909USA01379. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Cytogenetic analysis normal, Drug exposure during pregnancy, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with no pertinent medical history and no known drug allergies who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (lot# 662300/0100Y). There was no concomitant medication. The patient received her first dose of GARDASIL while pregnant. Pregnancy was normal to date. At the time of the report, the patient's gestational age was 8 weeks and 3 days. On an unspecified date, a urine pregnancy test was performed. The patient sought medical attention through an office visit. The patient's last menstrual period was 12-JUL-2009. Expected date of delivery was 18-APR-2010. Follow up information was received from a Registered Nurse (R.N.) concerning a 24 year old female patient with one previous pregnancy (delivered full term) and no known birth defects or infant complications in the previous pregnancy who on 11-AUG-2009 was vaccinated with the first dose of GARDASIL (lot# 662300/0100Y). Concomitant therapy used during the pregnancy included prenatal vitamins (unspecified) taken daily for the pregnancy. It was reported that the laboratory diagnostic tests have not been performed yet. The last menstrual period was on 12-JUL-2009 and the estimated delivery date was on 19-APR-2010. Follow-up information was received from a Registered Nurse (R.N.) concerning the 24 year old female patient. The nurse reported that the patient delivered a healthy baby. Follow-up information was received from a Registered Nurse (R.N.) concerning the 24 year old female patient with epilepsy and one previous pregnancy and 2 full term deliveries who on 11-AUG-2009 at 09:00 hrs was vaccinated IM with a first dose of GARDASIL (lot# 662300/0100Y) into the left upper outer quadrant. On 17-AUG-2009 (reported as 17-AUG-2010), at 13:31 hrs, the patient experienced redness, swelling and itching at the injection site, from which she recovered on an unspecified date. On 10-SEP-2009, the patient had a CF screen for genetic screening which resulted negative. On 10-SEP-2009, the patient was placed on prenatal vitamins on a daily basis for pregnancy. On 29-SEP-2009, the patient had ultrasound done for pregnancy dating (result: WNL) and a maternal serum alpha-fetoprotein test done for genetic screening (Pt.1, negative). On 27-OCT-2009, another maternal serum alpha-fetoprotein test was done (Pt.2, negative). During pregnancy, the patient also had otitis media and pharyngitis (onset date and outcome not reported). On 10-MAR-2010, the patient was placed on daily Z-PAK for the treatment of pharyngitis and otitis media. On 24-APR-2010, the patient gave birth to a normal male infant with no congenital anomalies (weight 9 lb 10 oz, length 21 /4", apgar score 9/9, head circumference 14'/4). Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Laboratory test normal, Otitis media, Pharyngitis, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with no pertinent medical history and no known drug allergies who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (lot# 662300/0100Y). There was no concomitant medication. The patient received her first dose of GARDASIL while pregnant. Pregnancy was normal to date. At the time of the report, the patient's gestational age was 8 weeks and 3 days. On an unspecified date, a urine pregnancy test was performed. The patient sought medical attention through an office visit. The patient's last menstrual period was 12-JUL-2009. Expected date of delivery was 18-APR-2010. Follow up information was received from a Registered Nurse (R.N.) concerning a 24 year old female patient with one previous pregnancy (delivered full term) and no known birth defects or infant complications in the previous pregnancy who on 11-AUG-2009 was vaccinated with the first dose of GARDASIL (lot# 662300/0100Y). Concomitant therapy used during the pregnancy included prenatal vitamins (unspecified) taken daily for the pregnancy. It was reported that the laboratory diagnostic tests have not been performed yet. The last menstrual period was on 12-JUL-2009 and the estimated delivery date was on 19-APR-2010. Follow-up information was received from a Registered Nurse (R.N.) concerning the 24 year old female patient. The nurse reported that the patient delivered a healthy baby. Follow-up information was received from a Registered Nurse (R.N.) concerning the 24 year old female patient with epilepsy and one previous pregnancy and 2 full term deliveries who on 11-AUG-2009 at 09:00 hrs was vaccinated IM with a first dose of GARDASIL (lot# 662300/0100Y) into the left upper outer quadrant. On 17-AUG-2009 (reported as 17-AUG-2010), at 13:31 hrs, the patient experienced redness, swelling and itching at the injection site, from which she recovered on an unspecified date. On 10-SEP-2009, the patient had a CF screen for genetic screening which resulted negative. On 10-SEP-2009, the patient was placed on prenatal vitamins on a daily basis for pregnancy. On 29-SEP-2009, the patient had ultrasound done for pregnancy dating (result: WNL) and a maternal serum alpha-fetoprotein test done for genetic screening (Pt.1, negative). On 27-OCT-2009, another maternal serum alpha-fetoprotein test was done (Pt.2, negative). During pregnancy, the patient also had otitis media and pharyngitis (onset date and outcome not reported). On 10-MAR-2010, the patient was placed on daily Z-PAK for the treatment of pharyngitis and otitis media. On 24-APR-2010, the patient gave birth to a normal male infant with no congenital anomalies (weight 9 lb 10 oz, length 21 /4", apgar score 9/9, head circumference 14'/4). Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female with no pertinent medical history and no known drug allergies who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (lot# 662300/0100Y). There was no concomitant medication. The patient received her first dose of GARDASIL while pregnant. Pregnancy was normal to date. At the time of the report, the patient's gestational age was 8 weeks and 3 days. On an unspecified date, a urine pregnancy test was performed. The patient sought medical attention through an office visit. The patient's last menstrual period was 12-JUL-2009. Expected date of delivery was 18-APR-2010. Follow up information was received from a Registered Nurse (R.N.) concerning a 24 year old female patient with one previous pregnancy (delivered full term) and no known birth defects or infant complications in the previous pregnancy who on 11-AUG-2009 was vaccinated with the first dose of GARDASIL (lot# 662300/0100Y). Concomitant therapy used during the pregnancy included prenatal vitamins (unspecified) taken daily for the pregnancy. It was reported that the laboratory diagnostic tests have not been performed yet. The last menstrual period was on 12-JUL-2009 and the estimated delivery date was on 19-APR-2010. Follow-up information was received from a Registered Nurse (R.N.) concerning the 24 year old female patient. The nurse reported that the patient delivered a healthy baby. Follow-up information was received from a Registered Nurse (R.N.) concerning the 24 year old female patient with epilepsy and one previous pregnancy and 2 full term deliveries who on 11-AUG-2009 at 09:00 hrs was vaccinated IM with a first dose of GARDASIL (lot# 662300/0100Y) into the left upper outer quadrant. On 17-AUG-2009 (reported as 17-AUG-2010), at 13:31 hrs, the patient experienced redness, swelling and itching at the injection site, from which she recovered on an unspecified date. On 10-SEP-2009, the patient had a CF screen for genetic screening which resulted negative. On 10-SEP-2009, the patient was placed on prenatal vitamins on a daily basis for pregnancy. On 29-SEP-2009, the patient had ultrasound done for pregnancy dating (result: WNL) and a maternal serum alpha-fetoprotein test done for genetic screening (Pt.1, negative). On 27-OCT-2009, another maternal serum alpha-fetoprotein test was done (Pt.2, negative). During pregnancy, the patient also had otitis media and pharyngitis (onset date and outcome not reported). On 10-MAR-2010, the patient was placed on daily Z-PAK for the treatment of pharyngitis and otitis media. On 24-APR-2010, the patient gave birth to a normal male infant with no congenital anomalies (weight 9 lb 10 oz, length 21 /4", apgar score 9/9, head circumference 14'/4). Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bacterial test, Chlamydia test, Drug exposure during pregnancy, Infection, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 15 year old female with asthma and seasonal allergy who on 30-OCT-2007, 19-MAY-2009 and 08-SEP-2009 was vaccinated intramuscularly with first, second and third dose, respectively of GARDASIL (lot number not reported). Concomitant therapy included albuterol, hydrocortisone cream and NASONEX. The nurse practitioner stated that the patient stated that her last menstrual period was in June 2009, and also told her that she had not had intercourse in the past three years. On 08-SEP-2009, when the patient was seen in the office, she was given a dose of FLAGYL for a trichomonas infection. The patient is going to be having an ultrasound completed on 15-SEP-2009 for prenatal evaluation and dating. She denied any difficulties with the pregnancy. Lab test performed included pregnancy urine at office (positive), "PAP smear", Gonorrhea and Chlamydia culture (results not provided). The patient sought medical attention at the office. Follow up information was received from a nurse practitioner. The patient's date of birth was reported. The nurse practitioner reported that the patient gave birth to a baby boy on 27-FEB-2010 at 38 weeks of gestation. It was a vaginal delivery with no complications and no sexually transmitted infections (STI). The patient is breastfeeding. The nurse practitioner has since seen the mom and baby in passing. It was noted that the patient was seen on 23-MAR-2010 by a resident. She mentioned that the baby is "very cute and sweet." She said as far as she knows everything looked normal with the baby but there was nothing specific mentioned in the resident's note in the patient's chart. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Anogenital warts, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Fungal infection
Clinical narrative: Information has been received from a medical assistant for the Pregnancy Registry for GARDASIL concerning a 23 year old female with no pertinent medical history reported and no known drug allergies who on 21-MAY-2009 and 29-JUL-2009 was vaccinated intramuscularly with her first 0.5mL dose and second 0.5mL dose, respectively of GARDASIL (lot numbers not reported). There was no concomitant medication. The medical assistant reported that after being administered her second dose, it was determined that the patient was pregnant. The patient was seen on 07-AUG-2009 and had a positive pregnancy test on that date. No problems were reported. The patient sought medical attention by contacting office by phone. Follow up information has been received from a medical assistant concerning a 23 year old female with Sickle cell trait and no previous pregnancies who on 29-JUL-2009 was vaccinated with her second dose of GARDASIL (lot number 662300/0100Y). Concomitant therapy included YASMIN for contraception (frequency reported as inconsistent). The patient's LMP was on 07-JUL-2009 and the estimated conception date was on 20-JUL-2009. The estimated delivery date is 13-APR-2010. Follow up information received from the medical assistant indicated that the patient's concomitant medications also included CONCEPT and "INTERJCA". On an unspecified date during her pregnancy the patient experienced anemia, genital warts, yeast infection and urinary tract infection. On 13-APR-2010 at 40 weeks from her last menstrual period, the patient gave birth to a female, who weighed 6 lb and 10 ounces. The baby's length was 20 3/4 inches; her Apgar score were 8/9. The baby was born with the following congenital anomalies pericardial effusion, intracranial ventriculomegaly, stomach duodenum, possible aneuploidy, alpha thalassemia trait ("after baby born no abnormalities"). The outcome of the patient's genital warts, yeast infection and urinary tract infection was unknown. The baby's experience has been captured on WAES # 0909USA01458B1. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: Information has been received from a medical assistant for the Pregnancy Registry for GARDASIL concerning a 23 year old female with no pertinent medical history reported and no known drug allergies who on 21-MAY-2009 and 29-JUL-2009 was vaccinated intramuscularly with her first 0.5mL dose and second 0.5mL dose, respectively of GARDASIL (lot numbers not reported). There was no concomitant medication. The medical assistant reported that after being administered her second dose, it was determined that the patient was pregnant. The patient was seen on 07-AUG-2009 and had a positive pregnancy test on that date. No problems were reported. The patient sought medical attention by contacting office by phone. Follow up information has been received from a medical assistant concerning a 23 year old female with Sickle cell trait and no previous pregnancies who on 29-JUL-2009 was vaccinated with her second dose of GARDASIL (lot number 662300/0100Y). Concomitant therapy included YASMIN for contraception (frequency reported as inconsistent). The patient's LMP was on 07-JUL-2009 and the estimated conception date was on 20-JUL-2009. The estimated delivery date is 13-APR-2010. Follow up information received from the medical assistant indicated that the patient's concomitant medications also included CONCEPT and "INTERJCA". On an unspecified date during her pregnancy the patient experienced anemia, genital warts, yeast infection and urinary tract infection. On 13-APR-2010 at 40 weeks from her last menstrual period, the patient gave birth to a female, who weighed 6 lb and 10 ounces. The baby's length was 20 3/4 inches; her Apgar score were 8/9. The baby was born with the following congenital anomalies pericardial effusion, intracranial ventriculomegaly, stomach duodenum, possible aneuploidy, alpha thalassemia trait ("after baby born no abnormalities"). The outcome of the patient's genital warts, yeast infection and urinary tract infection was unknown. The baby's experience has been captured on WAES # 0909USA01458B1. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a first dose of with GARDASIL (route and lot number not reported). The nurse reported that "after the patient received the first dose of GARDASIL", the patient called to physician's office and she stated that her menstrual period had stopped. The nurse reported the patient was going to be coming in to see the physician. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female patient who in 2007 was vaccinated with a dose of GARDASIL. The patient fainted after administration of HPV vaccine and was observed for thirty minutes. Medical attention was sought by an office visit. The patient recovered from syncope. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning a female who fainted after receiving a dose of GARDASIL sometime last year in 2008. The patient had sought medical attention, in the office. At the time of report the patient's status was unknown. This is one of several reports from the same source. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza
Clinical narrative: Information has been received from a physician concerning an 18 year old female full time student who on 14-JAN-2009 was vaccinated intramuscularly with a dose of GARDASIL (lot# 1423X, site of administration not reported). On 14-JAN-2009 the patient developed flu symptoms for 24 hours. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on 08-JUN-2009 was vaccinated with her first dose of GARDASIL. On the same date the patient experienced nausea, dizziness and lightheadedness. The patient's reaction to GARDASIL was the same to TYLENOL and aspirin. On an unknown date the patient recovered. The patient sought medical attention via speaking to nurse in office. Follow-up information was received from the registered nurse concerning a 22 year old female patient with depression, allergic rhinitis and TYLENOL allergy who on 08-JUN-2009 was intramuscularly vaccinated with her first dose of GARDASIL (lot number 662229/1497X) in her right deltoid. The patient was well at time of vaccination. It was reported that 5 to 10 minutes after administration, the patient became nauseated, dizzy, lightheaded and shaky. She reported this experience when she came in office for her second dose of GARDASIL. Because she stated that this response was similar with TYLENOL (which she was allergic to), after discussion, it was decided she should not take the second dose of GARDASIL. On 08-JUN-2009 the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of GARDASIL and experienced high fever for about 2-3 days that spiked up to 103 degrees and nose bleeds. The patient was in the physician's office for her second dose of GARDASIL. The physician stated that a fever over 102 degrees is a contraindication for continued doses. The patient's outcome is unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Blood electrolytes normal, Myalgia, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history or drugs allergies who on 13-JUL-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661954/1496X), intramuscularly. There was no concomitant medication. On 17-AUG-2009 the patient developed joint pain and muscle pain. The patient was evaluated in the office on 19-AUG-2009 and was complaining of myalgia of the upper extremities and arthralgia of bilateral elbows and knees. The physician stated she has ordered unspecified blood tests. At the time of this report the patient had not recovered. Follow up information received on 21-AUG-2009 from the physician indicated that the patient received a first dose of GARDASIL on 10-JUN-2009. She received a second dose of GARDASIL on 13-JUL-2009 (lot # 661954/1496X). The physician also reported that the patient had laboratory testing done on 14-AUG-2009 and her Rh factor, electrolytes, sedimentation rate and serum antinuclear antibodies test were all within normal limits and therefore did not warrant further investigation for RA. The health care professional contact during telephone follow-up could not supply the following information: patient name, lot number for the first dose and recovery status. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor negative
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history or drugs allergies who on 13-JUL-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 661954/1496X), intramuscularly. There was no concomitant medication. On 17-AUG-2009 the patient developed joint pain and muscle pain. The patient was evaluated in the office on 19-AUG-2009 and was complaining of myalgia of the upper extremities and arthralgia of bilateral elbows and knees. The physician stated she has ordered unspecified blood tests. At the time of this report the patient had not recovered. Follow up information received on 21-AUG-2009 from the physician indicated that the patient received a first dose of GARDASIL on 10-JUN-2009. She received a second dose of GARDASIL on 13-JUL-2009 (lot # 661954/1496X). The physician also reported that the patient had laboratory testing done on 14-AUG-2009 and her Rh factor, electrolytes, sedimentation rate and serum antinuclear antibodies test were all within normal limits and therefore did not warrant further investigation for RA. The health care professional contact during telephone follow-up could not supply the following information: patient name, lot number for the first dose and recovery status. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no pertinent medical history or any known drug allergy, who on an unspecified date was vaccinated with the first and only dose of GARDASIL (Lot number not reported). There was no concomitant medication. In May 2009 (reported as for 3 months), the reporter's daughter had been having dizziness. The patient's dizziness persisted. At the time of reporting the patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Gingival swelling
Clinical narrative: Information has been received from a physician assistant concerning a female who on 17-AUG-2009 was vaccinated with her first dose 0.5 mL of GARDASIL (Lot # was not provided). On 19-AUG-2009 the patient experienced gum swelling. The outcome of the patient's gum swelling was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 15 year old female who received the second dose of GARDASIL and a dose of tetanus shot (manufacturer unspecified) "sometime this week on 17-AUG-2009 and then the next day the patient developed a rash on her trunk. The physician reported that the patient was sent to the emergency room (name, address and phone number unspecified) to have the rash looked at but she was not admitted. The physician reported that they were unsure if the patient would receive the third dose of GARDASIL. "At the time of report the patient was recovering. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 26 year old female with no medical history or concurrent condition who on 19-AUG-2009 was vaccinated intramuscularly in the left deltoid with the first 0.5 mL dose of GARDASIL (lot# 662404/0312Y). There was no concomitant medication. The patient felt faint within a minute after vaccination on 19-AUG-2009. The patient did black out for about 10 seconds. Afterwards, she was sat down with her legs raised and ice was applied to her neck. The patient also mentioned that she did not eat anything that morning. The patient had recovered from the experience on 19-AUG-2009. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female "who fainted after receiving a dose of GARDASIL". Lot number was not available. The patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Personality change, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer with no medical history or concurrent condition concerning herself (a 9 year old female) who on 26-DEC-2008 was vaccinated with the first 0.5 mL dose of GARDASIL. She received the second and third dose of GARDASIL on 26-FEB-2009 and 26-JUN-2009 respectively. Lot# was not provided. There was no concomitant medication. The patient reported that she experienced severe headache and change in attitude after receiving first, second and third dose of GARDASIL. The patient sought medical attention. Allergy test and eye exam were performed. At the time of report the patient had not recovered. The patient also mentioned that when she was child she broke out in hives after taking AUGMENTIN (manufacturer unknown) and liquid Prednisone (manufacturer unknown). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Raynaud's phenomenon
Clinical narrative: Information has been received from a consumer concerning her daughter (a 14 year old female) with no medical history or concurrent condition who was vaccinated intramuscularly with 3 0.5 ml doses of GARDASIL "when it first came out". There was no concomitant medication. The patient developed Raynaud's Phenomenon "around the time she got GARDASIL". Caller was unaware if the patient developed symptoms before or after starting the series. The patient sought unspecified medical attention. Blood tests did not show anything that could have caused the AE. The patient had not yet recovered. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Skin irritation
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female patient who in 2007 was vaccinated with a second dose of GARDASIL. The nurse practitioner reported that after the patient received the second dose of GARDASIL, she experienced irritation and itching. The nurse practitioner also reported that the patient was recently detected with GARDASIL despite finishing the dosing schedule of GARDASIL in 2007. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning female about 17 years old who on unspecified dates was vaccinated IM with all three 0.5 ml dose of GARDASIL (lot number not reported). Recently, during the last cervical smear (PAP) the physician discovered that the patient developed high grade cervical dysplasia. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Vision blurred, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 17-AUG-2009 was vaccinated with a first dose of GARDASIL. Subsequently, that same day, on 17-AUG-2009, the patient experienced a headache that was on the top of her forehead, numbness of the right shoulder and arm, blurry vision in her right eye, and vomited once. The physician reported that the symptoms lasted "a couple of hours", and had not had any symptoms since. Medical attention was sought by calling the physician. Conflicting information has been received from a physician who reported: "No problems - Not sure why I received". Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning female about 17 years old who on unspecified dates was vaccinated IM with all three dose 0.5 ml doses of GARDASIL (lot number not reported). Recently, during the last cervical smear (PAP) the physician discovered that the patient developed high grade cervical dysplasia. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Paraesthesia, Sensation of heaviness
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no pertinent medical history and no drug allergies, who was vaccinated with her first dose of GARDASIL on 05-JAN-2009, the second dose on 31-MAR-2009, and the third dose on 04-AUG-2009 (Lot# 662404/0312Y). There was no concomitant medication. On 10-AUg-2009 which was six days after the third dose, the patient's whole right arm from shoulder to hand felt heavy, warm inside and tingly on the palm side of her hand. No treatment had been recommended. There were no labs and diagnostic tests performed. The patient made a phone call for medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 02-FEB-2010 was vaccinated with a dose of GARDASIL. On an unspecified date the patient developed rash, on her neck, arm, and back. The patient was treated with BENADRYL but the rash worsened and the patient went to an emergency room. At the time of this report the patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Drug exposure before pregnancy, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry Product, concerning her 17 year old daughter with allergic reaction to antibiotics, acne and no pertinent medical history who in 2008 was vaccinated with a dose of GARDASIL. Concomitant therapy included acne medication and NAUSEA. The consumer mentioned her daughter's pap smear was abnormal and believed it was due to GARDASIL. She also mentioned the doctor did not want to conduct the biopsy during her daughters pregnancy. A blood work was performed and the outcome was unknown. It was reported that the patient sought unspecified medical attention. The patient was 9 weeks pregnant at the time of the adverse event occurred. The patient's last menstrual period (LMP) was approximately 12-JUN-2009. Expected date of delivery (EDD) was approximately 19-MAR-2010. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 24 month old male patient who on approximately 13-AUG-2009 was vaccinated inadvertently with 0.5 ml of a dose of GARDASIL (Lot: 660612/0229X) I.M. instead of a dose of hepatitis A vaccine (inactive) (manufacturer unspecified) by human error. There was no adverse event reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Blood pressure increased, Drug exposure during pregnancy, Haemorrhage, Induced labour
Clinical narrative: Information has been received for the HPV vaccine pregnancy registry from a registered nurse concerning a 25 year old female patient with a history of birth control pills at the time of conception who on 11-MAY-2009 and on 27-JUL-2009 was vaccinated IM with a 0.5 ml first dose (Lot # 661766/0652X) and second dose (662404/0312Y) of GARDASIL, respectively. It was reported that the patient discovered to be pregnant on 12-AUG-2009 because of a urine pregnancy test performed which was positive. On 12-AUG-2009 an ultrasound was performed for dating purposes only. From the ultrasound it was estimated that the patient was 5 weeks pregnant at the time that the second dose of GARDASIL was administered. The estimated delivery date is 29-MAR-2010. Follow-up information has been received from a registered nurse concerning the patient with a history of an elective termination of a previously pregnancy in 2004. It was reported that on 12-AUG-2009, an ultrasound was performed for dating of pregnancy and revealed a small sub-chorionic bleed. The patient's last menstrual period was 22-JUN-2009. Other medications used during the patient's pregnancy included prenatal vitamins (unspecified). Follow up information was received from a registered nurse concerning a 25 year old female with a history of cervical dysplasia (LEGP 2003) and one previous pregnancy and one elective termination who on 11-MAY-2009 and on 27-JUL-2009 was vaccinated IM with a 0.5 ml first dose (Lot # 661766/0652X) and second dose (662404/0312Y) of GARDASIL, respectively. Other medications used during this pregnancy included prenatal vitamins. During the pregnancy, the patient experienced third trimester elevated blood pressure. The patient had a negative vaginal GBS culture. She was treated with TCA twice for condyloma. It was reported that on 23-MAR-2010 at 39 weeks and 1 day of gestation, the patient gave birth to a normal female infant with no congenital anomalies and no other complications, weighing 7 pounds and 14 ounces with an Apgar score of 4/9. Follow up information was received from a physician via medical records. It was noted that the patient was induced at 39 weeks due to borderline preeclampsia. On 26-MAR-2010, the patient's baby was seen again and she was receiving breastfeeding. The baby's experienced is captured in WAES 0908USA02725B1. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pre-eclampsia, Streptococcus test negative, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received for the HPV vaccine pregnancy registry from a registered nurse concerning a 25 year old female patient with a history of birth control pills at the time of conception who on 11-MAY-2009 and on 27-JUL-2009 was vaccinated IM with a 0.5 ml first dose (Lot # 661766/0652X) and second dose (662404/0312Y) of GARDASIL, respectively. It was reported that the patient discovered to be pregnant on 12-AUG-2009 because of a urine pregnancy test performed which was positive. On 12-AUG-2009 an ultrasound was performed for dating purposes only. From the ultrasound it was estimated that the patient was 5 weeks pregnant at the time that the second dose of GARDASIL was administered. The estimated delivery date is 29-MAR-2010. Follow-up information has been received from a registered nurse concerning the patient with a history of an elective termination of a previously pregnancy in 2004. It was reported that on 12-AUG-2009, an ultrasound was performed for dating of pregnancy and revealed a small sub-chorionic bleed. The patient's last menstrual period was 22-JUN-2009. Other medications used during the patient's pregnancy included prenatal vitamins (unspecified). Follow up information was received from a registered nurse concerning a 25 year old female with a history of cervical dysplasia (LEGP 2003) and one previous pregnancy and one elective termination who on 11-MAY-2009 and on 27-JUL-2009 was vaccinated IM with a 0.5 ml first dose (Lot # 661766/0652X) and second dose (662404/0312Y) of GARDASIL, respectively. Other medications used during this pregnancy included prenatal vitamins. During the pregnancy, the patient experienced third trimester elevated blood pressure. The patient had a negative vaginal GBS culture. She was treated with TCA twice for condyloma. It was reported that on 23-MAR-2010 at 39 weeks and 1 day of gestation, the patient gave birth to a normal female infant with no congenital anomalies and no other complications, weighing 7 pounds and 14 ounces with an Apgar score of 4/9. Follow up information was received from a physician via medical records. It was noted that the patient was induced at 39 weeks due to borderline preeclampsia. On 26-MAR-2010, the patient's baby was seen again and she was receiving breastfeeding. The baby's experienced is captured in WAES 0908USA02725B1. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Acoustic stimulation tests normal, Eye discharge, Lacrimation increased
Clinical narrative: Information has been received from a registered nurse via medical records concerning a 17 day old female who was born from a patient with a history of birth control pills, elective termination of a previous pregnancy in 2004 and cervical dysplasia who on 11-MAY-2009 and on 27-JUL-2009 was vaccinated IM with a 0.5 mL first dose (Lot # 661766/0652X) and the second dose (662404/0312Y) of GARDASIL, respectively. It was also reported that on 23-MAR-2010, the patient was given first dose of hepatitis B virus vaccine (manufacturer unknown) (dose, route and lot number not reported) in the hospital at birth. On an office visit on 26-MAR-2010, the patient's weight was 7 pounds and 8 ounces. On 09-APR-2010, the patient's baby was seen again. The patient's weight was 8 pounds and 10 ounces and her height was 20 1/2 inches. Physical examination was normal. Non-Specific Symptoms were detected. Hearing test was passed and the vision was not much crossed. The physician noted that the infant had "eye gunkiness" and watering of right eye and she was treated with erythromycin ointment. The vaccination plan and handouts were discussed with the patient. The diagnosis was a well 2 week old child. The mother's experience is captured in WAES 0909USA02725. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning an approximately 15 year old female patient who on 15-AUG-2009, was vaccinated with the first dose of GARDASIL (Lot # 660620/0571X). On 15-OCT-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660557/0072X). On 21-JAN-2009, the patient was vaccinated with the third dose of GARDASIL
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Unevaluable event
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter who in December 2008 finished her three doses series of GARDASIL. On approximately 31-JUL-2009 "three weeks ago", the patient developed throat infection and went to her physician's office on 17-AUG-2007. While in the office visit the patient was administered with a fourth dose of GARDASIL. The patient's final outcome was not reported. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Erythema
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a patient who on 13-AUG-2009 was vaccinated with a dose of GARDASIL (lot # 661766/0652X). The nurse mentioned that the patient pulled away during vaccination and with GARDASIL and the vaccine ran down the patient's arm. It was unknown how much vaccination was actually received. The patient's skin was turned a splotchy red; however it resolved within 15 minutes. The patient was upset about injection. At the time of reporting, the outcome of the patient was unknown. It was unknown if the patient sought medical attention. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient with no pertinent medical history, no drug reactions/allergies, who on 03-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # 0162Y). On 04-AUG-2009 the patient was vaccinated with the second dose of GARDASIL (Lot # 0455Y). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 11-AUG-2009, "1 week after the 2nd dose" the patient experienced a fever of 104 F, rash on the extremities that were mainly on the lower half, myalgia, fatigue and headache. There were unspecified emergency room test performed. The physician did not feel what the patient experienced was related to GARDASIL since the patient had no problems after the first dose. On an unspecified date, the patient recovered. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Blister, Dizziness, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female patient with no known drug reactions or allergies and no pertinent medical history, who on 09-SEP-2009 was vaccinated with the first dose of GARDASIL (Lot # 663452/0671Y). Concomitant therapy included MENACTRA. The nurse practitioner reported that on 10-SEP-2009 the patient developed nausea, dizziness, stomach ache, fever (100.5 degrees F) and blisters on both ears after vaccination with her first dose of GARDASIL. The reporter stated the blisters were on the top of the patient's ear, and were about 2 cm by 0.5 cm in size. The patient sought medical attention; she was seen in the office. At the time of the report the patient had not recovered. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Confusional state, Feeling abnormal, Loss of consciousness
Clinical narrative: Information has been received from a Medical Assistant (M.A) concerning a 15 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on approximately 16-AUG-2009 was vaccinated with the first 0.5 mL dose of GARDASIL intramuscularly. Concomitant vaccines given on the same day included MENACTRA and ADACEL. It was reported that on approximately 16-AUG-2009 the patient said her "arm felt really weird and then she passed out". The patient sought unspecified medical attention. There were no laboratory diagnostic tests performed. It was reported that she regained consciousness "about 5 seconds later but she was confused". The patient became reoriented "a few seconds later". It was also reported that the patient "was very nervous about getting the vaccinations" when she came to the office. It was reported that the patient had recovered at the time of the report. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Lymph node palpable
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with no drug reaction allergies, obesity, goiter and a history of sexually transmitted diseases who on 12-AUG-2009 was vaccinated with her first dose of GARDASIL in her right thigh. Subsequently the patient experienced swelling and pain at the injection site. The patient also had palpable lymph nodes. Ibuprofen had been recommend as a treatment. No labs were performed. The patient's swelling and pain at the injection site and palpable lymph nodes persisted. The patient sought medical attention (came into office). Additional information has been requested.