chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a female patient with amoxicillin allergy and no pertinent medical history who on 05-OCT-2009 and 14-DEC-2009 was vaccinated IM with the first and second dose of GARDASIL. Concomitant therapy included TRI-SPRINTEC. Two to three weeks following the second dose vaccination, the patient developed a lump at the injection. No complaint of redness, warmth, or discomfort noted. The same reaction occurred following both the first and second doses. The second dose was given in the left arm and the first dose was given in the right arm. The "lump" had resolved following the first dose. The patient had sought medical attention by phone call. There were no lab diagnostic tests performed. At the time of report the patient's status was recovering. Follow-up information has been received from a licensed practical nurse concerning this 22 year old female patient with no illness at time of vaccination and with amoxicillin allergy who on 14-DEC-2009 at 09:24 was vaccinated IM with the second dose of GARDASIL (Lot # 662304/1013Y) at left deltoid. On 06-JAN-2010 at 18:07 the patient had a slightly painful bump on her arm. Patient stated it happened after the first dose of GARDASIL but went away on it's own. Patient denied redness, warmth or drainage. At the time of report the patient's status was recovered. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Laboratory test abnormal, Vitamin B12 deficiency
Clinical narrative: Information has been received from an office manager concerning her 19 year old daughter with penicillin allergy. The family had a history of MS. On approximately 31-OCT-2009 she was vaccinated with a second dose GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 31-DEC-2009 the patient had ongoing numbness in her arms and legs. The patient had blood samples tests done (results not reported). The patient sought medical attention with a physician. At the time of this reported the patient had not recovered. Follow up information has been received from the office manager concerning her daughter. She stated that her daughter's blood tests revealed a vitamin B12 deficiency. The patient had recently received three vitamin B12 injections. It was reported that the patient had some improvement. The patient's mother stated that the patient's physician did not think that the patient's symptoms were GARDASIL related. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 19 year old female with penicillin allergy and no pertinent medical history, who on an unspecified date was vaccinated with the third dose of GARDASIL. Concomitant therapy included YAZ. On 05-JAN-2010 the patient developed a 5cm indurated red raised lump, the size of a lacrosse ball at the injection site. There were no labs or diagnostic tests performed. It was unknown if the patient sought medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Heart rate increased, Incorrect dose administered
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with tachycardia and sulfa allergy who on 09-AUG-2007, 15-OCT-2007, 26-MAR-2008 and 02-JUL-2009 was vaccinated with the first, second, third and fourth dose of GARDASIL (lot # not reported). There was no concomitant medication. On 16-JUL-2009, two weeks after the fourth dose of GARDASIL, the patient experienced a fast heart rate and severe acne. The patient sought medical attention via office visit. There were no laboratory diagnostics studies performed. At the end of October 2009, the patient had recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who was vaccinated with her first dose of GARDASIL and has a syncopal episode right before getting into her car. The patient recovered from her syncope. The nurse practitioner could not confirm that these events were definitely related to vaccination with GARDASIL. The practice began observing the patient for 15 minutes after the patient received vaccination as a result of the event. This is one of three reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Aphthous stomatitis, Gingival infection, Oral bacterial infection
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on unspecified date was vaccinated with a second dose of GARDASIL (manufacturer unspecified) (lot # not reported). The patient told to to the nurse that 30 days after receiving the second dose of GARDASIL she developed canker sores in her mouth which turned into a bacterial infection that went to her gums. 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: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 22 year old female who was vaccinated with a dose of GARDASIL (dose, route, and lot# not reported). The physician reported that the patient was then positive for HPV type 66. A HPV titer was performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient who on unspecified dates was vaccinated IM with all three doses of GARDASIL (Lot # not provided). The physician stated that the patient received all three doses of GARDASIL and "recently" came in for an annual exam and the tests came back ASCUS (atypical cells of undetermined significance). The patient sought unspecified medical attention. At the time of this report the patient's outcome was reported as not recovered. Follow up information has been received from the physician who stated that there was not an adverse reaction. The physician reported that the patient had an abnormal Pap following therapy with GARDASIL which is expected due to the many HPV virus subtypes. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician's assistant concerning a 19 year old female with no pertinent medical history and no drug allergies, who on 27-NOV-2006 was vaccinated with the first dose of GARDASIL, the second dose in January 2007 and her third dose in June 2007. There was no concomitant medication. The patient was not sexually active at that time. The patient became sexually active in September 2008. In December 2009, the patient had abnormal PAP test. The patient sought unspecified medical attention. At the time of the report, the patient had abnormal PAP test. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician's assistant concerning a 15 year old female who on an unspecified date was vaccinated with her second dose of GARDASIL. Subsequently the patient experienced amenorrhea for a couple months after administration of her second dose of GARDASIL. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from amenorrhea. Follow-up information has been received from a health professional concerning a 15 year old female student with "1.5 months without period" at the time of vaccination who on 27-OCT-2009 at 4:00 p.m. was vaccinated with the first dose of GARDASIL (lot # 663453/0249Y), and on 28-DEC-2009 at 4:00 p.m. was vaccinated with the second dose of GARDASIL (lot # 663453/0249Y). On 15-DEC-2009 the patient experienced amenorrhea. There were no laboratory studies performed. the patient's sister also experienced amenorrhea after vaccination with GARDASIL (MSD WAES#1001USA02084). Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Headache, Vomiting
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a 15 year old female who on 27-OCT-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL. On 18-JAN-2010 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL. It was reported that on approximately 18-JAN-2010 the patient developed headache, vomiting and stomach ache "for the past 10 hours". At the time of this report, the patient's symptoms persisted. The patient didn't sought medical attention. Follow up information was received from the physician who reported that there was no clear relationship between vaccine administration and vomiting. Follow-up information was received from the registered nurse. It was reported that that doctor determined that these events were not related with GARDASIL. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL and passed out immediately following her vaccination. The nurse practitioner could not confirm that these events were definitely related to vaccination with GARDASIL. The practice began observing the patient for 15 minutes after the patient received vaccination as a result of the event. This is one of three reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site reaction, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on unspecified dates was vaccinated with 3 doses of GARDASIL (no lot number given). The physician reported that the patient experienced injection site reactions after all 3 doses with the third dose being the most painful. The patient sought unspecified medical attention. This is one of two reports received from the same source. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient with seafood allergy, sulfa allergy and ibuprofen allergy who on 24-AUG-2009 was vaccinated IM with the first dose of 0.5 ml GARDASIL (lot # 663451/0216Y). Concomitant therapy included LOESTRIN 24 FE. When the patient saw the doctor on 22-DEC-2009 she said that she experienced hives after the injection. No time frame was offered. On an unknown date, the patient recovered from hives. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a Medical Assistant (MA) concerning a 15 year old female with no drug allergies who was vaccinated with a dose of GARDASIL (no lot number was given) 2 years ago. The patient almost passed out after the vaccine. This occurred when the MA was working at a pediatric office. At the time of report the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Immune system disorder, Soft tissue disorder
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unknown date was vaccinated with a first dose of GARDASIL (Lot No. not reported) along with three other vaccines, including tetanus (unspecified manufacturer). Subsequently the patient experienced "deterioration of her body tissue". The patient had been seen by eight different specialists and no one had been able to diagnose her. The consumer noted that the company should look into "immune disorders" associated with GARDASIL. At the time of the report, the patient had not recovered. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female who was vaccinated with 3 doses of GARDASIL series at another office. The patient had abnormal Pap smear on 21-DEC-2009, and tested positive for HPV post vaccination. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Drug exposure during pregnancy, Nausea, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a 26 year old female consumer with allergic reaction to erythromycin and prednisone and a history of papilloma viral infection prior to receiving GARDASIL (specific strains unspecified), for GARDASIL, a Pregnancy Registry product, concerning that on 20-DEC-2009 she was vaccinated with a third dose of GARDASIL. Suspect therapy included AFLURIA (unspecified manufacturer) at the same time. On approximately 29-DEC-2009 "two weeks ago" the patient started experiencing nausea until today (11-JAN-2010). On 08-JAN-2010, the patient conducted a urine home pregnancy test and it came back positive. The patient's last menstrual period was 07-DEC-2009, and estimated delivery date was 13-SEP-2010. The patient contacted physician for medical attention. At the time of the report, the patient had recovered from nausea. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from an office medical assistant concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL (which specified dose was unspecified). Subsequently the patient experienced a delayed period by one month. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Herpes simplex, Ultrasound antenatal screen
Clinical narrative: Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with a history of childhood asthma. The patient had 1 previous pregnancy with full term delivery, no pre-term deliveries, no spontaneous abortions, no elective terminations or fetal deaths. There were no birth defects in previous pregnancies but the baby was reported to be born with low birth weight. On 03-AUG-2009, the patient was vaccinated with a first dose of GARDASIL (lot# 662404/0312Y) and was pregnant. Concomitant therapy included prenatal vitamins. The patient's last menstrual period was on approximately 25-JUN-2009 and the estimated delivery date was on approximately 01-APR-2010. On 14-DEC-2009, the patient was given prenatal vitamins, one tablet daily. On 28-DEC-2009, the patient was given VALTREX for the treatment of Herpes simplex type 1 (HSV 1). On 29-DEC-2009, an ultrasound was performed for fetal dates/survey and the estimated delivery date was reported as 23-MAR-2010. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Pain, Pyrexia
Clinical narrative: Information has been received from a Nurse practitioner concerning a 19 year old female patient with no pertinent medical history and no known drug allergies who on an unspecified date was vaccinated with the first dose of GARDASIL 0.5 mL IM. On 28-DEC-2009, the patient was vaccinated with a second dose of GARDASIL 0.5 mL IM. The Nurse reported that the patient developed fever, body aches and anxiety within 8 hours of each dose. The symptoms resolved after 24 hours without requiring treatment in both instances. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Granuloma annulare
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated with a dose of GARDASIL. Subsequently the patient experienced granuloma annulare. The patient's outcome at the time of the report was unknown. The patient sought medical attention through an office visit. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness transient, Headache, Migraine with aura, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Information has been received from a Registered Nurse concerning her daughter an 18 year old female who on an unspecified date was vaccinated with 0.5 ml first dose of GARDASIL (route and lot number not reported). Concomitant therapy included tuberculin purified protein derivative (PPD test). The Nurse stated that "her daughter received the first dose of GARDASIL and the next day she experienced tingling in her fingers (date unspecified). After field hockey practice she started to lose vision and at first it was thought she was dehydrated, she was taken to the emergency room when she experienced shooting pain through the top of her head. Her vision came back and she was released from the emergency room. The patient went to a neurologist who performed an MRI (magnetic resonance imaging) (date not reported) which came back clear and the neurologist diagnosed her with ocular migraines (date unspecified). The patient had not received the second and third dose of GARDASIL. At the time of the report the outcome of the patient was recovered (date unspecified). No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a Registered Nurse concerning her daughter an 18 year old female who on an unspecified date was vaccinated with 0.5 ml first dose of GARDASIL (route and lot number not reported). Concomitant therapy included tuberculin purified protein derivative (PPD test). The Nurse stated that "her daughter received the first dose of GARDASIL and the next day she experienced tingling in her fingers (date unspecified). After field hockey practice she started to lose vision and at first it was thought she was dehydrated, she was taken to the emergency room when she experienced shooting pain through the top of her head. Her vision came back and she was released from the emergency room. The patient went to a neurologist who performed an MRI (magnetic resonance imaging) (date not reported) which came back clear and the neurologist diagnosed her with ocular migraines (date unspecified). The patient had not received the second and third dose of GARDASIL. At the time of the report the outcome of the patient was recovered (date unspecified). No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Retching
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on unspecified dates was vaccinated intramuscularly with her "first two doses" of GARDASIL and developed "dry heaves" for several hours following each of the vaccinations. The patient recovered on an unknown date. The patient called the pharmacist. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female patient with no  pre-existing allergies, birth defects, medical conditions and no illness at the time of vaccination who on 19-NOV-2009 at 15:45 pm was vaccinated IM in the left deltoid with the first dose of GARDASIL (Lot#663558/0819Y). On 19-NOV-2009 at 15:45 pm the patient experienced injection caused stinging sensation down arm. Since injection patient had pain, followed by numbness, when she lifted arm up high. The patient had sought medical attention by doctor visit. The doctor of medicine referred patient to physical therapy on 01-DEC-2009. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Cervical dysplasia, Dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a pharmacist concerning herself who in May 2009, was vaccinated with 0.5 ml of the first dose of GARDASIL IM, in July 2009 received 0.5 ml of the second dose of GARDASIL IM, and in December 2009 0.5 ml of the third dose of GARDASIL IM. Concomitant therapy included NUVARING. Three days after the third dose she had a PAP test and biopsy. The results show mild dysplasia of CIN1 and an aggressive type of HPV. No treatment at this time. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Colour blindness acquired, Optic neuropathy, Vision blurred, Visual acuity reduced, Vitamin B1 decreased
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no known drug reactions/allergies or pertinent medical history who on 30-JUL-2009 was intramuscularly vaccinated with the first dose of GARDASIL (lot#662518/0087Y0 0.5 mL and also was vaccinated with a dose of MENACTRA on the same date. On 12-OCT-2009 the patient was intramuscularly vaccinated with a second dose of GARDASIL (lot#660612/0229Y) 0.5 mL. The physician reported that after the second dose of GARDASIL, the patient complained of blurred vision and increased loss of vision. The patient was seen by a neuro-ophthalmologist and was diagnosed with bilateral optic neuropathy with color loss (date unspecified). Lab test were performed that showed a vitamin B1 deficiency. The physician reported that the patient would not get the third dose of GARDASIL because she was uncertain that the patient's experience was not hypersensitivity reaction. It was noted that the physician did not feel that the patient's vision loss was disabling. The physician saw the patient on 03-NOV-2009 at which time she noted improvement of the patient's symptoms, but no resolutions as of yet. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vitamin B1 deficiency
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with no known drug reactions/allergies or pertinent medical history who on 30-JUL-2009 was intramuscularly vaccinated with the first dose of GARDASIL (lot#662518/0087Y0 0.5 mL and also was vaccinated with a dose of MENACTRA on the same date. On 12-OCT-2009 the patient was intramuscularly vaccinated with a second dose of GARDASIL (lot#660612/0229Y) 0.5 mL. The physician reported that after the second dose of GARDASIL, the patient complained of blurred vision and increased loss of vision. The patient was seen by a neuro-ophthalmologist and was diagnosed with bilateral optic neuropathy with color loss (date unspecified). Lab test were performed that showed a vitamin B1 deficiency. The physician reported that the patient would not get the third dose of GARDASIL because she was uncertain that the patient's experience was not hypersensitivity reaction. It was noted that the physician did not feel that the patient's vision loss was disabling. The physician saw the patient on 03-NOV-2009 at which time she noted improvement of the patient's symptoms, but no resolutions as of yet. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with who was vaccinated with the first dose of GARDASIL and experienced amenorrhea for a few months. Patient is not pregnant. The patient's outcome was unknown at the date of the report. Patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Back pain
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL. The physician reported that she received a phone call from the patient's mother saying that the patient was experiencing back pain after GARDASIL. The patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from a Licensed Practical Nurse who stated that she did not know who this patient is. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning her daughter a 14 year old female with no medical history who received 2 doses of GARDASIL last summer in April 2009 and June 2009. In June 2009, after her second dose of GARDASIL the patient experienced fainted. The patient was treated in office. The same day of vaccination (in June 2009), the patient recovered from faint. The patient was fine with her initial dose. The patient's mother was considering not getting the third dose scheduled on 11-JAN-2010. This is one of several reports received from the same source. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 23-APR-2009 was vaccinated with the first dose of 0.5ml GARDASIL (Lot # 663454/0672Y), on 23-JUL-2009 with the second dose of 0.5ml GARDASIL (Lot # 663454/0672Y), and on 05-JAN-2010 with the third dose of 0.5ml GARDASIL (Lot # 663454/0672Y). On 06-JAN-2010 the patient's arm was sore at the injection site, and there were some swelling and redness. There were no labs or diagnostic tests performed. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Menstrual disorder
Clinical narrative: Information has been received from a doctor's nurse concerning a female patient who on an unspecified date was vaccinated intramuscular with the second dose of GARDASIL, 0.5 ml. The nurse reported that a couple days after getting her second dose of GARDASIL, the patient had her menstrual cycle and it was very heavy and abnormal. The patient's outcome was unknown was unknown. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Immediate post-injection reaction, Loss of consciousness, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from an office manager concerning a 17 year old female with no pertinent medical history and no drug allergies, who on 06-NOV-2009 was vaccinated with the first dose of GARDASIL (lot # 659054/0315Y) and on 08-JAN-2010 the second dose (lot #660612/0229X).  There was no concomitant medication.  The patient passed out immediately after the first vaccination and "cracked her head on the floor".  After the second vaccination, the patient passed out again while lying down in the office.  The patient also received seasonal flu vaccine (manufacturer unknown) after the second dose immediately after recovering from the GARDASIL vaccination.  There were no labs or diagnostic tests performed.  The patient sought medical attention while the events happened in office.  At the time of the report, the patient recovered.  Follow up information had been received from a physician concerning a 17 year old female with no pertinent medical history, illness at time of vaccination and no drug allergies, who on 08-JAN-2010 in the afternoon at approximately 3:00 pm was vaccinated with the second dose of GARDASIL (lot #660612/0229X) in the right deltoid.  Concomitant medication included a first dose of FLUZONE, (Sanofi Pasteur, lot # U3240AA) on 08-JAN-2010 in the afternoon at 3:00 pm in the left deltoid.  On an unspecified date, the patient experienced syncopal episode.  There were no labs or diagnostic tests performed.  The patient recovered from syncopal episode on 08-JAN-2010.  No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea, Oropharyngeal pain, Vomiting
Clinical narrative: Information has been received from a registered nurse for the GARDASIL pregnancy registry, concerning a 12 year old female patient with anxiety who on 04-DEC-2008, 02-FEB-2009 and 19-AUG-2009 was vaccinated IM with a 0.5 mL first, second and third dose of GARDASIL (LOT # for third dose 0670Y). Concomitant therapy included BUSPAR. It was reported that at the time of receiving the third dose of GARDASIL the patient was pregnant. On 20-AUG-2009, 24 hours after the third dose of GARDASIL was administered, the patient developed nausea and vomiting which the nurse attributed to the patient's pregnancy. No laboratory or diagnostic tests were performed. On an unknown date, the patient recovered from nausea and vomiting. The patient's last menstrual period was not reported and the estimated delivery date is 03-MAY-2010. Information received on 09-DEC-2009 contained the following adverse experiences: sore throat (onset on approximately 09-DEC-2009) which was treated with amoxicillin. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Antibody test abnormal, Immune system disorder
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with three doses of GARDASIL (lot # not given). The patient's mother stated that she believed GARDASIL caused anti-ovary antibodies to be produced. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Delivery, Drug exposure during pregnancy, Hypertension, Laboratory test normal
Clinical narrative: Information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with urinary tract infection and penicillin reaction/allergy with no pertinent medical history who on 10-JUL-2009 was intramuscularly vaccinated with the first dose of GARDASIL (Lot #662300/1674X) and is now pregnant. Concomitant therapy included PRENATE DHA and MACROBID. It was reported that the patient's last menstrual period (LMP) was 21-JUN-2009 and the estimated date of delivery (EDD) is 28-MAR-2010, the estimated conception date was 05-JUL-2009. It was also reported that the patient had no previous pregnancies or live births. On 08-SEP-2009 an ultrasound and an integrated screen were performed. The results were normal for both. On 12-OCT-2009, an integrated screen was performed again and was reported as normal. The patient sought medical attention by an office visit. There was no adverse effects reported. Follow up information has been received from the licensed practical nurse regarding the 26 year old female patient with penicillin allergy, hypothyroidism and hypertension with no previous pregnancies or live births who on 10-JUL-2009 was vaccinated with GARDASIL. Concomitant therapy included PRENATE. It was reported that the patient experienced hypertension, urinary tract infection, nausea and vomiting during pregnancy. On 14-AUG-2009 a Cystic fibrosis test was performed, the result was negative. On 19-AUG-2009, treatment with MACROBID was discontinued. On 08-SEP-2009 and on 12-OCT-2009, Maternal Serum Alpha Fetoprotein (MSAFP) test were performed, the results were within normal limits. On 18-JAN-2010, the patient was treated with ZOFRAN for nausea and vomiting. It was reported that on 17-MAR-2010, at 38 weeks and 3 days of gestation, the patient delivered a normal male baby (weight 4315 grams, the length was 20.5 inches, APGAR score was 8/9). The patient did not have complications during labor or delivery. The baby did not have congenital anomalies. There were no complications or abnormalities. At the time of the report, the outcome of the patient's worsening hypertension, nausea, vomiting, and UTI were unknown. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Ultrasound scan normal, Urinary tract infection, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with urinary tract infection and penicillin reaction/allergy with no pertinent medical history who on 10-JUL-2009 was intramuscularly vaccinated with the first dose of GARDASIL (Lot #662300/1674X) and is now pregnant. Concomitant therapy included PRENATE DHA and MACROBID. It was reported that the patient's last menstrual period (LMP) was 21-JUN-2009 and the estimated date of delivery (EDD) is 28-MAR-2010, the estimated conception date was 05-JUL-2009. It was also reported that the patient had no previous pregnancies or live births. On 08-SEP-2009 an ultrasound and an integrated screen were performed. The results were normal for both. On 12-OCT-2009, an integrated screen was performed again and was reported as normal. The patient sought medical attention by an office visit. There was no adverse effects reported. Follow up information has been received from the licensed practical nurse regarding the 26 year old female patient with penicillin allergy, hypothyroidism and hypertension with no previous pregnancies or live births who on 10-JUL-2009 was vaccinated with GARDASIL. Concomitant therapy included PRENATE. It was reported that the patient experienced hypertension, urinary tract infection, nausea and vomiting during pregnancy. On 14-AUG-2009 a Cystic fibrosis test was performed, the result was negative. On 19-AUG-2009, treatment with MACROBID was discontinued. On 08-SEP-2009 and on 12-OCT-2009, Maternal Serum Alpha Fetoprotein (MSAFP) test were performed, the results were within normal limits. On 18-JAN-2010, the patient was treated with ZOFRAN for nausea and vomiting. It was reported that on 17-MAR-2010, at 38 weeks and 3 days of gestation, the patient delivered a normal male baby (weight 4315 grams, the length was 20.5 inches, APGAR score was 8/9). The patient did not have complications during labor or delivery. The baby did not have congenital anomalies. There were no complications or abnormalities. At the time of the report, the outcome of the patient's worsening hypertension, nausea, vomiting, and UTI were unknown. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 24 year old female with no pertinent medical history and no known drug allergies, who on 11-NOV-2009 was vaccinated with the first dose GARDASIL 0.5ml intramuscularly (lot#0670Y). No issues were reported after the first dose. On 11-JAN-2010 patient was vaccinated with the second dose of GARDASIL 0.5ml intramuscularly (lot#0981Y). There was no concomitant medication. On 13-JAN-2009 the patient developed an itchy rash on her hands and the back of her knees (*welts and hives about a quarter of an inch across on the knees*). Patient called the office and BENADDRYL cream was recommended by the physician and BENADRYL tablet at night time was also recommended. No lab diagnostics studies performed. At the time of this report the patient was recovering. Follow-up information was received from the licensed practical nurse who reported that the patient was vaccinated with the second dose of GARDASIL on the left arm. Patient stated that she had hives. At the time of reporting, it was unknown if the patient had recovered.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (route and lot # unknown) and experienced a headache after receiving the vaccine. The patient sought medical attention by contacting the physician. At the time of the report that patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Laboratory test, Rash pruritic
Clinical narrative: Information has been received from a physician's assistant concerning a female patient "in her 20's" with unspecified medical history and no drug reactions or allergies reported, who in early November 2009 and in early December 2009 was vaccinated with the first and second dose of GARDASIL (route and lot # unknown) respectively. Concomitant medication was unspecified. On an unspecified date, the patient experienced itchy bumps on her opposite arm (not the arm where the injection was given) and her back, after the first and second doses of GARDASIL. The physician's assistant also reported that the doses were separated by only one month. Lab diagnostic studies performed were unspecified. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a healthcare worker concerning a 25 year old female patient who "3 weeks ago", on approximately 19-NOV-2009, was vaccinated with the first dose of GARDASIL (LOT# not provided) 0.5 mL. The healthcare worker reported that "3 weeks ago", on approximately 19-NOV-2009, the patient developed rash on her chest and arm after that lasted for four days after vaccination with GARDASIL. No lab tests were performed. The patient sought unspecified medical attention. On approximately 23-NOV-2009, the patient had recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician assistant for GARDASIL, a Pregnancy registry product, concerning a 25 year old female patient with depression and no known drug allergies who on 23-DEC-2009 was intramuscularly vaccinated with a 0.5 mL dose of GARDASIL (Lot# 663454/0672Y). Concomitant therapy included RISPERDAL, CLARITIN and NASONEX. It was reported that the patient LMP was in September 2009 and the estimated date of delivery (EDD) is approximately on 08-JUN-2010. The physician assistant reported that on 23-DEC-2009, the patient became dizzy within 30 minutes after received GARDASIL. No lab tests were performed. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with allergic reaction to REGLAN who on an unspecified date in October 2009, was vaccinated with the first dose of GARDASIL (lot#, route and site of administration not reported), and on an unspecified date the patient was vaccinated with the second dose of GARDASIL (lot#, route and site of administration not reported) from a different office. "About one week after the second dose of GARDASIL", the patient experienced significant abdominal pain. The patient was referred to the physician and would be sent for stool check and upper GI test later that week. The reporter felt that significant abdominal pain was not related to therapy with GARDSAIL but the patient's mother believed that it was because she healthy prior to receiving GARDASIL. At the time of this report, the patient's outcome was not reported. Follow up information has been received from the physician who stated that the patient was vaccinated with the vaccine at previous office. Child form transferred had family allergies, pain began after she was vaccinated with vaccine. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Information has been received from a Registered Nurse concerning a 12 year old female patient without a pertinent medical history or without drug reactions or allergies who on 02-DEC-2009 was vaccinated with her 0.5 ml first dose of GARDASIL intramuscularly in the deltoid region of the left arm. Concomitant medications were not reported. The reporter mentioned that on 02-DEC-2009 the patient developed redness on, warmth and itching on the ulnar aspect of the left lower arm 45 minutes after receiving GARDASIL. No laboratory or test diagnostics were performed. It was reported that the nurse applied cold compress and BEANDRYL gel topically to the affected area and symptoms resolved within 1 hour. Follow up has been received from the registered nurse regarding the 12 year old female patient with no known drug reactions or allergies or pertinent medical history who on 02-DEC-2009 was intramuscularly vaccinated with her first 0.5 ml dose of GARDASIL (Lot#660553/0070X) in the deltoid muscle of the left arm. It was reported that approximately 30 min later, on 02-dec-2009, the patient reported to the school clinic complaining of severe itching of radial aspect of the left forearm. The patient was examined and an itching area of approximately 6 inches which was erythematous and warm, that resemble phlebitis that disappeared very quickly. It was reported that there was no mark that indicated possible injury, sting or bite in the immediate area and that there was no inflammation presented at the time or later. An ice pack was applied and within 20-30 min all symptoms and signs had disappeared. It was reported by the registered nurse that a correct injection technique was performed and that when the needle was inserted in to the muscle no blood was withdrawn. The registered nurse stated that it was difficult to determine if the event was related to the administration of GARDASIL, because there was some distance between the reaction and the injection site. Other causes such insect bite could not be ruled out. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Biopsy, Diarrhoea, Endoscopy, Laboratory test
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient who on 06-Nov-2008 was vaccinated with a first IM dose of GARDASIL (Lot # 661044/0548X) into her right arm. On 30-Dec-2008 the patient was vaccinated with as second IM dose of GARDASIL (Lot # 661703/0651X) into her left arm and on 16-APR-2009 was vaccinated with a third dose of GARDASIL (Lot # 661952/1129X) into her right arm. Since the patient received the third dose of GARDASIL she has had really bad abdominal pain on and off. The pain has worsened and been more persistent now since she finished the vaccination series. She also has had emesis and diarrhea. The patient was seen by a gastroenterologist (GI). An endoscopy with a biopsy and "lots of lab work" had been performed with no results provided. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient who on 06-Nov-2008 was vaccinated with a first IM dose of GARDASIL (Lot # 661044/0548X) into her right arm. On 30-Dec-2008 the patient was vaccinated with as second IM dose of GARDASIL (Lot # 661703/0651X) into her left arm and on 16-APR-2009 was vaccinated with a third dose of GARDASIL (Lot # 661952/1129X) into her right arm. Since the patient received the third dose of GARDASIL she has had really bad abdominal pain on and off. The pain has worsened and been more persistent now since she finished the vaccination series. She also has had emesis and diarrhea. The patient was seen by a gastroenterologist (GI). An endoscopy with a biopsy and "lots of lab work" had been performed with no results provided. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot #, route and site of administration not reported). It was reported that the patient passed out right after receiving the first vaccination and then the patient was able to leave the office. At the time of this report, the patient had recovered. The reporter felt that passed out was not related to therapy with GARDASIL. The reporter and the patient's mother feel the experience may have occurred because the patient was anxious before receiving the vaccination. The patient was going to receive second dose of GARDASIL. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Drug exposure during pregnancy, Nausea, Pregnancy test positive
Clinical narrative: Information has been received from an 18 year old female consumer, for GARDASIL, a Pregnancy Registry product who on 29-JUN-2009 was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). There was no concomitant medication. The patient has been experiencing nausea and abdominal pain after receiving vaccine. The patient reported that since she missed her period in July 2009, she conducted a home urine pregnancy test a couple of days ago and the result came back positive. The patient's last menstrual period was on 08-JUN-2009, the estimated delivery date was 15-MAR-2010. The patient did not seek medical attention. At the time of report, the patient did not recover. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot#, route and site of administration not reported). Subsequently, the patient had an abnormal pap test after vaccination. Unspecified medical attention was sought via office visit. Pap test was performed with ASCUS (atypical squamous cells of undetermined significance) result. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Hyperhidrosis, Immediate post-injection reaction, Pallor, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient with no known allergies who on 22-OCT-2009 was vaccinated with a first dose of GARDASIL. Concomitant therapy included "birth control" that the patient has been taking for a long time. Immediately post-vaccination the patient became diaphoretic, pale, lips blue and became unresponsive for 3 to 4 seconds. Code blue was called and oxygen administered. Blood pressure readings were 110/60 and 124/80, and her pulse was 102. The patient recovered in the office and was able to drive herself home. During a follow-up conversation the patient indicated to the physician that she fully recovered. Follow up information has been received from a licensed practical nurse who confirmed that on 22-OCT-2009 the patient was vaccinated with a first dose of GARDASIL (Lot #663558/0819Y). The patient did not receive any concomitant vaccination at that time. Follow up information has been received from a licensed practical nurse who indicated that a Code Blue was called when the patient became diaphoretic, pale, lips blue and became unresponsive for 3 to 4 seconds. She explained that Code Blue is an urgent Care Response. The responders are Urgent Care Physicians and also certain members of the staff that are trained to respond in an emergency. The patient regained consciousness quickly and the patient stated that she felt better. Oxygen was administered as safety precaution only. The patient recovered. Additional information has been requested.