chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from an employee at a physician's office concerning a 21 year old female patient who on 14-JUL-2009 was vaccinated with the first dose of GARDASIL (lot number not reported). After the vaccination, the patient fainted and her blood pressure dropped. Unspecified medical attention was sought. It was unknown if there were lab studies performed. At the time of the report, the patient recovered from these events. The patient recovered on 14-JUL-2009. Follow-up information received from an other health professional concerning the 21 year old, 138 pounds weight, 5 feet 7 inches height female patient with no pertinent medical history and no known allergies who on 14-JUL-2009 at 12:00 was vaccinated IM in her left deltoid with the first dose of GARDASIL (lot number 662404/0312Y). After the vaccination, the patient was standing and bent over to pick up something she had dropped and passed out for less than 30 seconds. The patient hit her head hard on floor and she was sent to emergency room (ER) for lump. It was noted that the hospital never sent the office a note about the visit. At the time of the report, the patient had recovered from these events. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Head injury, Loss of consciousness, Syncope
Clinical narrative: Information has been received from an employee at a physician's office concerning a 21 year old female patient who on 14-JUL-2009 was vaccinated with the first dose of GARDASIL (lot number not reported). After the vaccination, the patient fainted and her blood pressure dropped. Unspecified medical attention was sought. It was unknown if there were lab studies performed. At the time of the report, the patient recovered from these events. The patient recovered on 14-JUL-2009. Follow-up information received from an other health professional concerning the 21 year old, 138 pounds weight, 5 feet 7 inches height female patient with no pertinent medical history and no known allergies who on 14-JUL-2009 at 12:00 was vaccinated IM in her left deltoid with the first dose of GARDASIL (lot number 662404/0312Y). After the vaccination, the patient was standing and bent over to pick up something she had dropped and passed out for less than 30 seconds. The patient hit her head hard on floor and she was sent to emergency room (ER) for lump. It was noted that the hospital never sent the office a note about the visit. At the time of the report, the patient had recovered from these events. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Sciatica
Clinical narrative: Information has been received from a physician assistant (P.A.) and medical assistant concerning a 19 year old female with no medical history or drug allergies who on 20-FEB-2009 was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL (lot # 659655/0940X). Concomitant therapy included DEPO-PROVERA. The patient experienced back pain in May 2009. She went to the emergency room and was diagnosed with sciatica. An unspecified person at the emergency room told the patient that the sciatica was caused by GARDASIL given back in February 2009. Doses 1 and 2 were administered at a different facility and the physician assistant and medical assistant did not have the dates of administration or lot numbers. The patient returned to the office of the physician assistant and medical assistant in June 2009 and informed them of the AE. At that time, the patient still had back pain (not recovered) and was having physical therapy. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a 25 year old female with a history of migraine who "in February or March, 2009", was vaccinated IM with the first dose of GARDASIL 0.5ml. On 14-JUL-2009 she got IM her second dose of GARDASIL 0.5ml. There were no concomitant medications. Afterwards the patient developed a headache. She said that she thought that the headache was more likely "due to stress than it was to the vaccine". No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Loss of consciousness, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a healthy female who never had any problems, who in approximately October 2008, was vaccinated intramuscularly with her second 0.5mL dose of GARDASIL (lot number not reported). The physician reported that the patient "passed out within 24 hours of getting the second dose of GARDASIL" (in approximately July 2008). The series was discontinued after the second dose. The patient was sent to the emergency room for "a complete work up" and "all tests came back normal". The patient was not admitted. The physician noted that there was no adverse event after the first dose of GARDASIL. The patient recovered within an unspecified time. This is one of two reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Inappropriate schedule of drug administration, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 year old female who was off schedule not further specified in the GARDASIL series. The patient received her second dose of GARDASIL greater than 6 months ago, and the first dose was given 6 months before the second dose. There was no concomitant medication. The patient had abnormal PAP test. The patient had had an abnormal PAP with CIN 1 and CIN 2 (cervical intraepithelial neoplasia). HPV type 53 was identified as the type in this abnormal PAP. At the report time the outcome was unknown. Follow-up information indicated that no adverse reaction occurred. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Loss of consciousness, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a healthy female who never had any problems, who "about a year ago", in approximately July 2008, was vaccinated intramuscularly with her second 0.5mL dose of GARDASIL (lot number not reported). The physician reported that the patient "passed out within 24 hours of getting the second dose of GARDASIL" (in approximately July 2008). The series was discontinued at this point so the third dose was not given. The patient was sent to the emergency room for "a complete work up" and all tests came back normal. The patient was not admitted. The physician noted that there was no adverse event after the first dose of GARDASIL. The patient recovered within an unspecified time. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a pharmacy intern concerning a female who was vaccinated with an unspecified number of doses of GARDASIL. The patient currently had hand and foot warts. The patient sought medical attention. At the report time the patient's hand and foot warts persisted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Clonus, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who the last month, in approximately June 2009, was vaccinated with the second dose of GARDASIL (Lot number not reported) 0.5 mL. The last month, in approximately June 2009, the patient experienced syncope with chronic movements that lasted for about 2 minutes after getting the second dose of GARDASIL. Subsequently, the patient recovered. The patient sought unspecified medical attention. Follow up information has been received from a licensed practical nurse who stated that they could not pull the chart to provide event details. The Health Care Professional contacted during telephone follow-up could not supply the following information: (patient name, date of birth, dates of vaccination/therapy, date of event and recovery status. No further information is available at this time.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria, Vaccine positive rechallenge
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 17 year old female who from 01-JUL-2008 was vaccinated IM with a first dose of GARDASIL (Lot# 660553/0070X) and a second dose of GARDASIL (Lot#660616/0570X). After the first and second dose the patient developed rash and one week after the second dose was given the patient developed hives. The patient had sought medical attention, spoke to medical assistant. At the time of report the patient had recovered but the third dose had not been given. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from an office manager concerning a 12 year old female patient who was vaccinated with a first dose of GARDASIL (lot# 662229/1497X, expiration 15-APR-2011, site and route not reported) on 16-JUN-2008, the second dose (lot# 662229/1497X, expiration 15-APR-2011) on 18-MAY-2009 and the third dose (lot# 662229/1497X, expiration 15-APR-2011) on 13-JUL-2009. After receiving the second dose of GARDASIL, the patient had injection site lump and tenderness that lasted for 7 weeks. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hair texture abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female with no pertinent medical history and no allergies who was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot# 660387/1967U) on 30-JAN-2009 and the second 0.5 ml dose of GARDASIL (lot# 661846/1312X) on 10-APR-2009. Concomitant therapy included hormonal contraceptives (unspecified) and ADDERALL TABLETS. In approximately February 2009, the patient's hairdresser noticed that the ends of her hair were become straight. The patient normally had curly hair. No lab diagnostics studies were performed.  At the time of reporting, the patient had not recovered. The patient sought medical attention through a phone call. Follow up information has been received from a medical assistant concerning a 22 year old female with allergy to ciprofloxacin and no illness at the time of vaccination who on 30-JAN-2009 at 03:39p.m. and on 10-APR-2009 at 10:36 a.m. was vaccinated intramuscularly into the left deltoid with first dose (lot number 660387/1967U) and second dose (661846/1312X), respectively of GARDASIL. It was reported that the patient stated her curly hair began to straighten after the first dose of GARDASIL and got even worse after the second dose. The patient has not received her third dose due to this. The patient recovered on an unknown date. No further information is available.
Sex: U
Vaccine: DTAP, HEP, HPV4, IPV, MMR, MNQ, TD, VARCEL
Symptoms: Drug exposure during pregnancy, Premature baby
Clinical narrative: Information has been received from a physician concerning a preterm infant who was born after his/her mother was vaccinated with the first dose of GARDASIL on 08-MAY-2009. On 08-MAY-2009, the patient also received the first dose of RECOMBIVAX B (MSD) (dose, route, lot# not reported), the first dose of VARIVAX (Merck) (MSD) (dose, route, lot# not reported) and a dose of hepatitis A virus vaccine unactivated (manufacturer unknown) (dose, route, lot# not reported). On 14-JUL-2009, the patient received a dose of MMR II (MSD) (lot#663797/0424Y) (dose and route not reported), a dose of RECOMBIVAX B (thimerosal free, lot# 662391/0377Y), a dose of VARIVAX (Merck) (lot# 664234/0500Y) and a dose of GARDASIL (lot# 658490/0802U). Concomitant therapy included MENACTRA, DTAP (unspecified), POLIOVIRUS vaccine (unspecified) and TD. It was reported that the patient was born on 05-SEP-2009, at 34 weeks gestation. It was a preterm delivery. The preterm infant weighed 4 pounds and 6 ounces. It was reported that the baby was fine and no reported problems. The mother's experiences have been captured in WAES # 0907USA02625. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, VARCEL
Symptoms: Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received from a Registered Nurse (R.N), for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female with no pertinent medical history and no allergies who on 08-MAY-2009 was vaccinated with the first dose of GARDASIL (dose, route, lot# not reported). The nurse reported that the patient had received vaccinations while pregnant. On 08-MAY-2009, the patient also received the first dose of RECOMBIVAX HB (MSD) (dose, route, lot# not reported), the first dose of VARIVAX (Merck) (MSD) (dose, route, lot# not reported) and a dose of VAQTA (manufacturer unknown) (dose, route, lot# not reported). On 14-JUL-2009, the patient received a dose of MMR II (MSD) (lot# 663797/0424Y) (dose and route not reported), a dose of RECOMBIVAX HB (thimerosal free, lot# 662391/0377Y), a dose of VARIVAX (Merck) (lot# 664234/0500Y) and a dose of GARDASIL (lot# 658490/0802U). Concomitant therapy included MENACTRA, DTAP, poliovirus vaccine inactivated (unspecified) and TD. The patient said her last menstrual period was June 2009, but it had also been reported that she was 6 months pregnant on 16-JUL-2009. The estimated delivery date was on 23-OCT-2009. The patient sought medical attention through an office visit. Follow up information was received from a Registered Nurse (R.N) who reported that the patient was referred to an obstetrician and she did not know any information about the baby.  Follow up information was received which reported that the patient delivered her baby on 05-SEP-2009 at 34 weeks of gestation. It was a preterm delivery. The preterm infant weighed 4 lb 6oz. The reporter stated that the baby was fine, and not reported problems. The patient was seen for her postpartum visit on 20-OCT-2009 and has not been back since. The baby's experience has been captured in WAES # 0907USA02625B1. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who on 08-JUL-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL. Concomitant therapy included YASMIN. After receiving the dose the patient developed swelling on her arm at the injection site and a red and swollen index finger on the same side that the injection was given. The patient had sought medical attention, phone call. The patient had recovered on an unspecified date. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: DTP, HPV4, MNQ
Symptoms: Axillary pain, Neck pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (lot number not reported). Concomitant vaccination included MENACTRA and DTP (manufacturer unknown). Subsequently, the patient experienced neck pain and axillary pain. She was prescribed MOTRIN and rest. The physician mentioned that the patient is a tall girl. The patient sought medical attention by making an office visit. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on 16-JUL-2009 was vaccinated with the second dose of GARDASIL (Lot number 662229/1497X) 0.5 mL IM. On 16-JUL-2009, the patient "fainted" and "hit her head on the table next to her right after getting her second GARDASIL shot". They did a TB test just before giving her the GARDASIL. On the same day, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Feeling of body temperature change, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 19 year old female with unspecified drug reactions/allergies and medical history who was vaccinated IM with a first 0.5 ml dose of GARDASIL (route and lot number not reported). The physician stated that "after getting vaccinated with her first dose of GARDASIL. It was unspecified if the laboratory tests were performed. Therapy was discontinued "after the adverse event occurred". At the time of the report the outcome of the patient was unspecified. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning a 19 year old female with no medical history reported and no known drug allergies and no illness at the time of vaccination who on 14-MAY-2009, at 02:34p.m., was vaccinated into the left deltoid with first dose of GARDASIL (route not reported, lot number 659054/0315Y). There was no concomitant medication. On 16-MAY-2009 the patient experienced on and off chills, vomiting for one week, fever for three days and hot and cold sweats. No laboratory testing was done. Subsequently, the patient recovered from on and off chills, "nauseated", vomiting, fever, and hot and cold sweats. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on 26-MAY-2009 was vaccinated with the third 0.5 ml dose of GARDASIL (lot number not reported). On 30-JUN-2009 the patient experienced syncope after the vaccination. At the time of the report, the patient recovered. It was reported that the patient did not experience any adverse event from the first and second dose of GARDASIL. This is one of three reports from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN, TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient who on 09-OCT-2008 was vaccinated with the first dose of GARDASIL (lot number unspecified). Concomitant therapy included VARIVAX (MSD), DTAP and meningococcal vaccine (unspecified). Two months after received the first dose the patient came into the office to receive the second dose. But at that time the patient was not ready for the second dose since after the first dose the patient experienced a fever for two days. No medical attention was sought. The patient did not receive the second dose of GARDASIL until 13-JUL-2009. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Oligohydramnios, Ultrasound scan abnormal, Vaginitis bacterial
Clinical narrative: Information has been received from a health professional for GARDASIL, a Pregnancy Registry product, concerning a female who was vaccinated with GARDASIL. Subsequently the patient became pregnant. Follow-up information has been received from a certified nurse midwife for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with a history of 1 pregnancy and 1 live birth with no birth defects or infant complications and a history of low grade squamous intraepithelial lesion (LGSIL) - cervix neoplasm stage I (CIN I) and cervix neoplasm stage II (CIN II) who on 08-JUL-2009 was vaccinated with the first dose of GARDASIL (lot #661046/0546X). On 21-JUL-2009 an ultrasound test was performed for gestational dating and revealed a 9 week intrauterine pregnancy. Her LMP was unknown. Expected date of delivery was 17-FEB-2010. In follow-up the certified nurse midwife reported that on approximately 16-JUL-2009 the patient developed bacterial vaginosis (BV). The patient was treated with FLAGYL, 500mg, twice daily. On 19-FEB-2010, the patient experienced oligohydramnios during the labor/delivery and delivered a normal, healthy male baby with no congenital anomalies weighing 7 pounds, 6 ounces and APGAR score of 8/9. There was not diagnostic test during pregnancy. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Weight increased
Clinical narrative: Information has been received from a female consumer concerning her 22 year old daughter with no medical history and no drug allergies, who was vaccinated with all three doses of GARDASIL. The therapy started over one year ago. The daughter started to gain weight shortly after her 3rd dose of GARDASIL in approximately November 2008 late fall. Concomitant medication included "the mini pill". There were no labs and diagnostic tests performed. The patient hadn't sought medical attention. At the time of the report, the patient's status was unknown. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy abnormal, Loop electrosurgical excision procedure, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a roughly 22 year old female who completed the GARDASIL series (0.5ml/3 shots). The patient developed CIN 2, 3 after the series. At the report time the outcome was unknown. Follow up information was received from a nurse practitioner on 27-JUL-2009: The patient received the GARDASIL on the following dates: the first dose on 17-OCT-2008, Lot# 660557/0072X; the second dose on 12-DEC-2008, Lot# 661703/0651X; the third dose on 06-APR-2009, Lot# 661846/1312X. In November 2007 the patient's Pap smear results were atypical squamous cells of undetermined significance (ASCUS) with negative high risk. On 17-OCT-2008, the patient's Pap smear was positive for HPV. The patient received the first dose of GARDASIL on 17-OCT-2008. The patient's Colposcopy was negative. The patient was a recent converter to HPV. On 06-APR-2009, the patient's Pap smear results were ASCUS, positive for HPV. The patient had received the third dose of GARDASIL on 06-APR-2009. On 29-MAY-2009 the patient had a Colposcopy which revealed moderate dysplasia, Focal High-grade, CIN 2. On 10-JUL-2009 the patient had a LEEP Procedure, which revealed Mild dysplasia, CIN 1. The patient had a scheduled follow-up appointment for 18-Jan-2010. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient with no pertinent medical history and no known drug allergies who on 28-OCT-2008 was vaccinated IM with a third 0.5ml dose of GARDASIL (lot # not reported). There was no concomitant medication. The patient started to have headaches everyday after receiving her third dose of GARDASIL. The patient saw the nurse practitioner on an unspecified date. At the time of the report, the patient had not recovered. Follow up information from a nurse practitioner indicated that onset of acute headache was on 28-OCT-2007 (previously reported as 28-OCT-2008), the same day of immunization with the second dose of GARDASIL. The patient experienced new daily persistent headache. The onset of adverse event might be coincidental with immunization. On 11-DEC-2008, a computed axial tomography (CT) with/without contrast was performed and the result was normal. On 02-NOV-2009, a magnetic resonance imaging (MRI) and mean reticulocyte volume (MRV) were performed and the results were normal. No illnesses were reported at the time of vaccination. The patient's new daily persistent headache was considered to be disabling. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an approx 12 year old female with rhinitis allergic and obesity who on 16-SEP-2008 was vaccinated with a dose of GARDASIL, 0.5 ml, IM (Lot #659184/0843X). There was no concomitant medication. Physician reported that the patient developed a syncopal episode. The physician considered the syncopal episode occurred after the patient left the office. The patient went to the emergency room and was hospitalized for 3 days for her syncopal episode. It is noted on the patient's chart that when she received dose 1, she had a rash (the rash was present before she received Dose 1). She was prescribed hydrocortisone cream and BENADRYL. The patient has not received any additional doses of GARDASIL. At the time of this report, the patient was recovered. This is one of several reports received the same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old female who in June 2009, was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot number not reported). Concomitant vaccination included ADACEL. In June 2009, after receiving the vaccination the patient started vomiting and had a fever of 103 degrees. She vomited 20 times in 24 hours. After 24 hours of the vaccination, the patient was then given promethazine and the AE went away. Unspecified medical attention was sought. It was also reported that in August 2009, the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot number not reported). Concomitant vaccination included MENACTRA. Subsequently the patient experienced the same AE. The patient was again given promethazine and the AE went away. The patient stopped to receive the GARDASIL. Follow-up information was received from a employee in the physician's office concerning a 12 year old female patient with a medical history of diabetes insipidus who on 15-JUN-2009 was vaccinated intramuscularly into the arm with the first dose of GARDASIL (lot number 660616/0570X, expired date 02-NOV-2010) and on 21-AUG-2009 was vaccinated intramuscularly into the arm with the second dose of GARDASIL (lot number 661952/1129X, expired date 12-MAR-2011). On 21-AUG-2009 at 18:00 the patient experienced fever, severe vomiting requiring antiemetics. On an unspecified date the patient recovered. Fever and severe vomiting were considered to be an other important medical event by the reporter. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 17 year old female who on an unknown date was vaccinated with a 0.5 ml dose of GARDASIL.  No lot number was provided.  Concomitant therapy included a dose of MENACTRA on the same day.  About 2 weeks after vaccination with GARDASIL the patient was hospitalized in the pediatric intensive care unit and was diagnosed with guillain-Barre syndrome.  At the time of report the patient was recovering.  Follow up information was received from a Medical Assistant on 01-SEP-2009 via telephone reported that a patient's mother had reported that she heard that a patient developed Guillain-Barre Syndrome 2 weeks after the patient received GARDASIL.  The Medical Assistant stated that the patient was treated at another hospital.  The patient was not a patient in Nurse Practitioner's office.  The health care professional contacted during telephone follow-up could not supply the following information:  patient name, date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, healthcare provider name and contact information.  Attempts to verify the existence of identifiable patients have been unsuccessful.  The reporter considered guillain-barre syndrome to be immediately life-threatening.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Back pain, Fatigue, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 26-AUG-2009 was vaccinated with the first dose of GARDASIL.  On 29-AUG-2009 the patient experienced back pain, joint pain, generalized injection site pain, fatigue and knee pain.  At the time of the report all the patient's symptoms persisted.  No laboratory tests were performed.  The patient sought medical attention by a phone call.  Follow up information was received from a Certified Medical Assistant.  It was reported that the 13 year old patient with skin disorder and no known drug allergies on 26-AUG-2009 was vaccinated with a dose of GARDASIL (Lot # 0558U, valid for rotavirus vaccine live (human-bovine) vaccine); no other vaccines were administered on the same day.  Concomitant therapy included BACTRIM and EPIDUO.  There were no labs/diagnostic studies performed.  The patient was treated symptomatically with rest, fluids, and OTC analgesics.  The patient could not go to school due to her fatigue and received a physician's note which excused her from school until 14-SEP-2009.  Although the office had not seen or heard from this patient since 02-SEP-2009, the Certified Medical Assistant assumed the patient had recovered as no school absence extension was requested.  Fatigue was considered to be disabling.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Disorientation, Dizziness, Fatigue, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with a "history of syncope after injections" and no known drug allergies who on 17-AUG-2009, was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (lot number 658271/0558X). There was no concomitant medication. On the same day, the patient fainted and exhibited tonic-clonic movements lasting one minute immediately after receiving GARDASIL. The patient experienced fatigue and headache after returning home. The symptoms resolved in two days without requiring treatment. No lab tests were performed. The patient sought unspecified medical attention. Follow up information was received from the registered nurse via phone call. She stated that the patient did not receive any concomitant vaccinations when the first dose of GARDASIL was administered. Right after the GARDASIL vaccination was given to the patient she state, "I am going to pass out". The patient was seated at that time and placed in a reclining position. The patient had loss of consciousness (LOC) with tonic-clonic movements for about 45 seconds. The patient regained loss of consciousness and was at first disoriented. The patient became oriented and stated that she had a headache. The patient went home accompanied by her mother. The patient's mother called the office to state that the patient had extreme fatigue and a headache. The patient went to bed and slept for about six hours. The registered nurse stated that the patient's mother was contacted (date not reported) and the patient had recovered. Follow up information was received from the registered nurse regarding a 16 year old female who was vaccinated intramuscularly in the right deltoid with first 0.5mL dose of GARDASIL (lot number 658271/0558X). The registered nurse reported that after vaccination the patient promptly passed out, ammonia salts were passed under her nose, and then the patient went into tonic-clonic movements of extremities that lasted 30-45 seconds, the patient came to with a headache on top of head and was disoriented for a few seconds, patient's vital signs were stable. It was reported that the patient's mom reported that patient went straight home and could barely make it up to her bed because of extreme fatigue and slept for three hours (previously reported as about six hours). The patient headache lasted for three days (previously reported as two days). The patient was eating, drinking and going about her usual activities of daily living by the day after the injection. At the time of the report the patient had recovered. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with a "history of syncope after injections" and no known drug allergies who on 17-AUG-2009, was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (lot number 658271/0558X). There was no concomitant medication. On the same day, the patient fainted and exhibited tonic-clonic movements lasting one minute immediately after receiving GARDASIL. The patient experienced fatigue and headache after returning home. The symptoms resolved in two days without requiring treatment. No lab tests were performed. The patient sought unspecified medical attention. Follow up information was received from the registered nurse via phone call. She stated that the patient did not receive any concomitant vaccinations when the first dose of GARDASIL was administered. Right after the GARDASIL vaccination was given to the patient she state, "I am going to pass out". The patient was seated at that time and placed in a reclining position. The patient had loss of consciousness (LOC) with tonic-clonic movements for about 45 seconds. The patient regained loss of consciousness and was at first disoriented. The patient became oriented and stated that she had a headache. The patient went home accompanied by her mother. The patient's mother called the office to state that the patient had extreme fatigue and a headache. The patient went to bed and slept for about six hours. The registered nurse stated that the patient's mother was contacted (date not reported) and the patient had recovered. Follow up information was received from the registered nurse regarding a 16 year old female who was vaccinated intramuscularly in the right deltoid with first 0.5mL dose of GARDASIL (lot number 658271/0558X). The registered nurse reported that after vaccination the patient promptly passed out, ammonia salts were passed under her nose, and then the patient went into tonic-clonic movements of extremities that lasted 30-45 seconds, the patient came to with a headache on top of head and was disoriented for a few seconds, patient's vital signs were stable. It was reported that the patient's mom reported that patient went straight home and could barely make it up to her bed because of extreme fatigue and slept for three hours (previously reported as about six hours). The patient headache lasted for three days (previously reported as two days). The patient was eating, drinking and going about her usual activities of daily living by the day after the injection. At the time of the report the patient had recovered. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who in 2008, was vaccinated with her first and only dose of GARDASIL (lot # not reported), intramuscularly. The physician reported that on 21-AUG-2008, the patient had developed Guillain-Barre Syndrome after receiving vaccination with GARDASIL vaccine and was hospitalized in a hospital. On an unknown date, the patient was released from the hospital after she recovered. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager concerning an 11 year old female patient who on 20-JUN-2009 was vaccinated with the first 0.5 mL dose of GARDASIL intramuscularly. It was reported that a few days later the patient fainted. No injuries noted. The patient was seen in the hospital. It was reported that the patient recovered on an unknown date. This is one of two cases from the same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Condition aggravated, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 15 year old female patient with CEFZIL and amoxicillin allergy and a history of syncope with blood draws who on 02-SEP-2009 was vaccinated IM with the first 0.5 mL dose of GARDASIL (LOT # 662404/0312Y). The patient concomitantly received FLUMIST (LOT # 500763P) and MENACTRA (LOT# U2925AA). On 02-SEP-2009 the patient fainted after getting the GARDASIL and then as the physician was coming to her, she experienced tonic-clonic movements for a short period of time. No laboratory or diagnostic tests were performed. It was reported that no treatment was needed and that the patient was not sent to the emergency room. It is unknown if the patient's mother will request subsequent GARDASIL doses. On an unknown date, the patient recovered. Upon internal review tonic-clonic movement was considered to be an other important medical event. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Condition aggravated, Dyskinesia, Fall, Loss of consciousness, Movement disorder
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female patient with a history of syncope vasovagal who "about 2 months ago" in approximately August 2009, was vaccinated with a dose of GARDASIL (route and lot # unknown).  The nurse practitioner reported that "about 2 months ago" a patient fainted after her first dose of GARDASIL and also had a seizure like episode after tonic clonic movements.  The patient sought medical attention at the nurse's office.  At the time of this report the patient was recovered.  Additional information has been requested.  Follow up information has been received from a nurse practitioner who reported that the patient received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on the same day as GARDASIL.  The nurse practitioner stated that the diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid was given first in one arm and then GARDASIL was given in the opposite arm, within seconds of receiving the second shot, the patient fell back "jerked" and lost consciousness for a few seconds.  The patient immediately woke up and asked what had happened.  The patient's vital signs were assessed and remained in the office for about 15 minutes before she was able to leave.  When the patient left she seemed to have fully recovered with no lasting effects.  The nurse practitioner further noted that the patient had experienced a vaso-vagal response from a blood draw previously (date not reported).  Upon internal review patient's "tonic - clonic movement and had a seizure like episode" was considered as an other important event (OME).
Age: 22.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female patient with a history of syncope vasovagal who "about 2 months ago" in approximately August 2009, was vaccinated with a dose of GARDASIL (route and lot # unknown).  The nurse practitioner reported that "about 2 months ago" a patient fainted after her first dose of GARDASIL and also had a seizure like episode after tonic clonic movements.  The patient sought medical attention at the nurse's office.  At the time of this report the patient was recovered.  Additional information has been requested.  Follow up information has been received from a nurse practitioner who reported that the patient received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on the same day as GARDASIL.  The nurse practitioner stated that the diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid was given first in one arm and then GARDASIL was given in the opposite arm, within seconds of receiving the second shot, the patient fell back "jerked" and lost consciousness for a few seconds.  The patient immediately woke up and asked what had happened.  The patient's vital signs were assessed and remained in the office for about 15 minutes before she was able to leave.  When the patient left she seemed to have fully recovered with no lasting effects.  The nurse practitioner further noted that the patient had experienced a vaso-vagal response from a blood draw previously (date not reported).  Upon internal review patient's "tonic - clonic movement and had a seizure like episode" was considered as an other important event (OME).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Health Care Professional concerning an 18 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that on 17-JUL-2009 the patient fainted three times and was ultimately taken to the hospital. The outcome of the patient was unknown. Follow up information was received from a Health Care Professional who stated that the patient received the immunizations in another clinic. It was reported that she was not a patient of the Health Department and she did not have other records. No further information is available.
Sex: M
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome, Off label use
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of GARDASIL.  The patient was in the physician's care currently, but the patient's experience did not happen while the patient was under her care.  His vaccination was considered to be an off label utilization of GARDASIL in a male patient.  The patient reported to the physician that shortly after he was vaccinated with GARDASIL, he was diagnosed with Guillain-Barre syndrome.  The outcome of the patient was unknown.  Upon internal review Guillain-Barre syndrome was considered to be another important medical event.  All telephone attempts to contact the reporter have been unsuccessful.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old female with allergy to metals (aluminum) who on 08-MAY-2009 was vaccinated intramuscularly with the first dose 0.5 mL of GARDASIL vaccine (yeast, LOT # was not provided).  On 11-MAY-2009 the patient experienced hives.  The outcome of the patient was unknown.  She sought unspecified medical attention.  Follow up information has been received from a physician concerning a 14 year old female who reported no allergies at the time of vaccination.  On approximately 11-MAY-2009 the patient experienced hives on her entire body.  On 27-MAY-2009 she saw ears, nose and throat doctor who prescribed BENADRYL, climetide and ATARAX.  On 4-JUN-2009 the patient made an appointment to see an allergist.  On 17-JUN-2009 she was referred by a physician to hospital and was placed on Steroids.  Hives was considered to be an other important medical event by the physician.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with allergies to penicillin and DESOGEN and no pertinent medical history who on 08-JUN-2009 and 08-AUG-2009 was vaccinated IM with the first (lot# 661952/1129X) and the second (lot# 661046/0381X) 0.5ml doses of GARDASIL. There was no concomitant medication. The nurse reported that the patient experienced nausea within 24 hours of receiving her first dose of GARDASIL. She also experienced nausea, vomiting, and diarrhea within 24 hours of receiving her second dose of GARDASIL on 08-AUG-2009. She was still experiencing symptoms on 13-AUG-2009 and was treated with PHENERGAN and IMMODIUM. No lab diagnostics study was performed. At the time of the report, the patient's outcome was unknown. Nausea (both episodes), vomiting and diarrhea were considered to be disabling. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a certified nurse midwife concerning a 25 year old female student with no known drugs allergies, who on 06-MAR-2009 was vaccinated with a second dose of GARDASIL (lot # 661531/1311X), intramuscularly into the left deltoid.  Three weeks post vaccination the patient developed severe hives and was hospitalized.  The patient recovered on an unspecified date.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gestational diabetes, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from two registered nurses for the pregnancy registry for GARDASIL concerning a 19 year old female patient with no pertinent medical history and no known drug allergies, who on 09-OCT-2008 was vaccinated with the first dose of GARDASIL (lot#660618/0572X) and on 03-DEC-2008 was vaccinated with the second dose of GARDASIL (lot#660618/0572X). No concomitant medication. Patient then found out she was pregnant. Last Menstrual Period 02-DEC-2008, estimated delivery date 08-SEP-2009. Patient sought medical attention via office visit. Urine pregnancy test performed. Pregnancy is normal to date. Follow-up information has been received from a registered nurse. It was reported that the patient has a history of an abnormal pap smear positive for Low Grade Squamous intraepithelial lesion on 9-OCT-2008 and "CPO" Cervical Intraepithelial Neoplasia grade I (CINI). This is her first pregnancy. On 15-JAN-2009 patient had an ultrasound done which showed the patient is 6 weeks and 4 days pregnant. Estimated date of confinement 6-SEP-2009. Follow-up information has been received from the registered nurse regarding the pregnancy outcome of the patient. It was reported that the patient delivered a healthy female on 31-AUG-2009 who weighted 3845 grams. The baby was "absolutely fine, with no problems". Her Apgars were 8 and 9 at 1 and 5 minutes respectively. "The only complication in the pregnancy was the development of gestational diabetes for the mother, but her BMI (body mass index) was 34 - she was obese prior to her pregnancy". There were no negative outcomes related to the GARDASIL vaccine.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a  dose of GARDASIL (lot # not available) "in arm". Subsequently, "the patient experienced pain and tenderness at injection site after receiving a dose of GARDASIL. These symptoms persisted for 6 weeks", and then the patient had recovered. There were no labs and diagnostic tests performed. The patient had sought medical attention. Follow-up information has been received concerning the 23 year old patient (weighing 100 pounds and height reported as "5'00") who on 06-MAY-2009 at 08:12 am, was vaccinated with her first dose of GARDASIL (lot # 1423X) in the left deltoid. At 8:55 AM on 06-MAY-2009, the patient started sweating then said "I feel like I am going to pass out". The physician was called and the patient was laid down on the examination table. Blood pressure was monitored and patient was fine after thirty minutes. She came back on 10-JUN-2009 complaining of arm hurting at left deltoid vaccination area. At the time of the report, the patient's status was unknown. No further information is available.