chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 16-year-old white female student, with no known relevant medical history nor drug allergy, who on 15-JAN-2007 was vaccinated IM in her left deltoid with the first dose of GARDASIL (lot # 653650/0697F).  Concomitant therapy included ALESSE, ASTELIN and RHINOCORT.  On 26-FEB-2007, the patient experienced headache and myalgia.  On 27-FEB-2007, her temperature was 101 degrees Fahrenheit.  Medical attention was sought and the events required ER/DR visit.  Laboratory test showed that all CBC and ESR were negative.  On 23-MAR-2007, the patient was vaccinated IM in her left deltoid with the second dose of GARDASIL (lot # 653650/0697F).  Subsequently on 24-MAR-2007, she experienced "ST" and headache.  On 26-MAR-2007, her temperature was of 101.5 degrees Fahrenheit, she also experienced bodyache.  The patient's outcome was unknown.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Registered Nurse concerning a 14 year old female with a history of back pain and pin in hip, and no drug reactions/allergies, who on 04-FEB-2009 was vaccinated with the first dose of GARDASIL (lot# 661766/0652X), 0.5 ml intramuscular into her left arm. There was no concomitant medication. On 04-FEB-2009 the patient experienced some pain as the injection went into her arm. This pain went away but then two weeks later the patient began to experience swelling of the injection site area. It was the size of a palm and was hot to the touch. There was no redness. The patient then wasn't able to lift up her arm because of the pain. She also developed numbness of her whole arm down to her hand. On 19-FEB-2009, it was numb nut only from the elbow down to her hand. It was not as tender but it still hurt. There was less swelling. On unspecified date, the patient sought unspecified medical attention, no lab diagnostics studies performed. The patient was not recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with the first dose of GARDASIL (lot# not reported) 0.5ml, injection four or six weeks ago. Concomitant therapy included hepatitis A virus vaccine (unspecified) and Mananjacocus. The patient experienced hives after getting first dose of GARDASIL. On unspecified date, the patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a company representative concerning a female who was vaccinated with GARDASIL (LOT# not reported).  After getting the GARDASIL, the patient had unknown AE and would be on TV that night.  The outcome of the patient's adverse events was not reported.  It was reported whether the patient sought medical attention.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Information has been received from a 20 year old female healthcare student who on 6-FEB-2009 was vaccinated with a first dose of GARDASIL. On 6-FEB-2009 the patient reported she felt like she had the flu, was achy and had a fever. The patient was off work for about two days. The patient recovered on approximately 11-FEB-2009. The patient sought unspecified medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 14 year old female with asthma and no known drug allergies who in JUL-2008, was vaccinated IM with the first dose of GARDASIL 0.5 ml (Lot # 0151X), and in DEC-2008, was vaccinated IM with the second dose of GARDASIL 0.5 ml (Lot # 660389/1968U).  The patient was pregnant at the time of vaccination (gestation-about- 5-6 months).  Concomitant therapy included MSD, XOPENEX and albuterol inhaler (manufacturer unknown).  The patient was currently experience diarrhea.  The outcome of the patient's adverse events was not reported.  It was reported that the patient sought medical attention:  office visit.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a female 21 years old who on 14-DEC-2007 was vaccinated with the first doses of GARDASIL 0.5 ml. On 12-FEB-2008 the patient was vaccinated with the second dose of GARDASIL and on 26-JUN-2008 was vaccinated with the third dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently in 2008 the patient had an abnormal pap smear result after completing the three doses of GARDASIL 0.5 ml. Disability and life threatening is unknown. The patient's abnormal pap smear persisted. The patient sought unspecified medical attention. Additional information is not available.
Sex: F
Vaccine: HPV4
Symptoms: Adverse drug reaction
Clinical narrative: Information has been received from a female consumer who on an unknown date, was vaccinated with GARDASIL (lot # not reported).  Subsequently the patient experienced severe side effects.  The patient was told that the reason she had the side effects was because she sat down for 15 minutes after administration.  It was unspecified if the patient sought medical attention.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a patient's mother concerning a 19 year old female who was vaccinated with second of GARDASIL. The patient's mother reported that after the administration of the second dose (unknown date), her daughter experienced rash around the umbilical and tops of both thighs. The patient was taken to a dermatologist and was prescribed an unspecified topical cream. The mother stated that the cream did not improve the systems but that rash resolved "eventually" on an unknown date. On an unspecified date, the patient was vaccinated with the third dose of GARDASIL. The reporter said that the patient developed a similar rash, with the same distribution, after the third dose. The mother stated that the second occurrence of the rash developed "just recently" and at the time of the report had not been resolved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 17-FEB-2009 was vaccinated with the first dose of GARDASIL (lot number, route an site of administration not reported).  It was reported that "the patient was in the office to receive the first dose of GARDASIL and right after receiving the first dose the patient fainted".  The physician reported that they had helped the patient up then she recovered, so she was ok to leave the office.  The physician also mentioned that the patient did not have anything to eat before getting the first dose of GARDASIL.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 02-DEC-2008 was vaccinated with the first dose of GARDASIL (lot no. and route not reported) and MENACTRA.  On 12-DEC-2008 when the patient was done with the vaccination, she left the room and passed out in the elevator.  The physician reported that the patient did not have injury when she passed out.  The patient was brought back to the clinic and after a few minutes she was fine and left the clinic.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from the immunization coordinator concerning a 20 year old female patient who in approximately September 2008, was vaccinated with the first dose of GARDASIL.  On an unknown date, was vaccinated with the second dose of GARDASIL.  On 18-FEB-2008, the patient came in to receive the third dose of GARDASIL and mentioned that a day after receiving the first and second dose of GARDASIL she developed a rash on her abdomen, and then a couple days later the rash would resolve.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a female patient who on 26-OCT-2007 was vaccinated with the first dose of GARDASIL (Lot # 659435/1265U) 0.5ml. On 18-JAN-2008 was vaccinated with the second dose of GARDASIL (Lot # 658556/1060U) 0.5ml. On 23-MAY-2008 was vaccinated with the third dose of GARDASIL (Lot # 660389/1968U) 0.5ml. Concomitant therapy included YAZ. The patient experienced headaches in the form of severe migraines specifically during her periods after receiving GARDASIL. At the time of the report, the patient had not recovered from the adverse event. The patient sought unspecified medical attention. Additional information has been requested.  3/25/09 MR and vax rec recwived from PCP. OV 10/26/07 for c/o heavy periods q 2 weeks.  Placed on OC and given HPV#1. OV 1/18/08 for c/o headache x 4 days with ear congestion and rhinorrhea.  Assessment:  Sinusitis.  Eustachian tube dysfunction.  HPV#2 given. Returned 1/31/08 with c/o RLQ pain, initially acute and sharp, now persistant. Slightly decreased appetite. PE (+) for guarding and mild rebound in RLQ. Sent for pelvic sono which was (-). Returned 4/9/08 with c/o dizziness and shakiness x several weeks. Pt always feels cold, has had some blurred vision which lead to brief black-outs of vision. (+) nausea. Assess:  Anemia. Seen 4/22/08 for dysmenorrhea. Seen 5/23/08 with c/o headache x 1 week. Assess:  Anemia.  HPV#3 given. OV 9/9/08 with c/o headaches which began in March/April intermittently, now constant with blurred/double vision. Sent for CT and ophth consult. Still reporting migraines with period. Stopped med due to loss of taste and hand and foot numbness. Seen 1/13/09 for bloody nose and bruising on upper extremities. CBC OK. Started on Celexa.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal non-stress test, Pyrexia
Clinical narrative: Information has been received from a Registered Nurse for the pregnancy registry for GARDASIL, concerning a 25 year old female patient with anxiety disorder and papanicolaou smear abnormal in 2007 resulting in a loop electrosurgical excision procedure, who on 28-AUG-2007 was vaccinated with the first dose of GARDASIL (lot# 658558/1061U), on 30-OCT-2007 was vaccinated with the second dose of GARDASIL (lot# 659964/1978U) and on 02-MAY-2008, was vaccinated with the third dose of GARDASIL (lot# 659437/1266U) while pregnant.  On an unspecified date, a non stress test was performed (results not provided).  Concomitant therapy included LEXAPRO and PREVACID.  The nurse reported that the patient who had completed the HPV vaccine series was hospitalized for delivery and delivered a healthy baby on 31-DEC-2008.  The patient had a post partum fever.  On 31-DEC-2008, the patient recovered.  Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: HPV4
Symptoms: Off label use, Protein urine present, Urine abnormality, Urine analysis abnormal
Clinical narrative: Information has been received from a physician concerning a 38 year old male with hypertension who on 13-FEB-2009 was vaccinated with a dose of GARDASIL.  On 15-FEB-2009, the patient noticed "foaminess" to his urine.  The patient was evaluated in the office on 16-FEB-2009 and a dipstick check of the urine revealed the presence of protein.  Complete blood count, comprehensive metabolic panel, urinalysis, serum and urine protein electrophoresis, sed rate, ANA, urine microalbumin, and protein/creatinine ratio have been ordered but at the time of report, the results was pending.  At the time of the report the patient was not recovered.  The patient sought unspecified medical attention in the office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a dose of GARDASIL (lot number not reported).  The patient's mother reported to the physician that her daughter experienced nausea and vomiting for three days.  The patient recovered on an unspecified date.  The patient's mother believed that nausea and vomiting were related to therapy with GARDASIL.  The patient did not seek for medical attention.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who was vaccinated with the second dose of GARDASIL (lot # not reported) 0.5ml intramuscularly. Concomitant therapy included SUDAFED taken that morning. On 18-FEB-2009 "the patient got very pale, curled up into the fetal position, and fainted". Later on the patient was conscious and "lying on sofa" In the doctor's office. Patient sought unspecified medical attention. No lab diagnostics studies performed. Events improved after stopping therapy and reappeared after reintroduction. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female patient with a history of jump roping injury who was vaccinated with GARDASIL.  Subsequently the patient reported that she experienced stiff, swollen and achy at the injection site in her arm.  The reporter stated that later they found out the symptoms was having in the arm the patient did not receive GARDASIL in and the experience was from a jump roping injury.  At the time of this report, the outcome was unknown.  It is unspecified the patient sought medical attention.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Oedema peripheral, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Information has been received from a consumer concerning her 28 year old daughter with no pertinent medical history, allergies or drug reactions, who was vaccinated with the first dose of GARDASIL, on 29-MAY-2007 and was vaccinated with the third dose in November 2008.  There was no concomitant medication reported.  The reporter stated that in November 2008 (also reported as about a month after receiving the last dose) her daughter started experiencing pain and swelling of feet and arms, especially on her left side.  It was also reported that she woke up because of the pain in her extremities and shoulders.  She was diagnosed with rheumatoid arthritis in December 2008.  Laboratory test performed included "blood work" and "x-rays" (no results were provided).  The patient's rheumatoid arthritis persisted.  The patient sought unspecified medical attention.  Follow up information has been received from a registered nurse concerning a 28 year old female with a history of mild dysplasia cervix who on 29-MAY-2007 was vaccinated intramuscularly (IM) in right deltoid (RD) with first 0.5mL dose of GARDASIL (lot number 657736/0389U), on 07-AUG-2007 was vaccinated IM in left deltoid with second 0.5mL dose of GARDASIL (lot number 657868/0523U) and on 23-NOV-2007 (previously reported as November 2008) was vaccinated IM in RD with third 0.5mL dose of GARDASIL (lot number 659437/1266U).  There was no concomitant medication.  The nurse reported that the she did not have information about the patient rheumatoid arthritis and therefore cannot comment on her condition.  The nurse was unable to provide any information on the primary physician of the patient as she only had his/her last name.  Additional information has been requested.
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning a female who on 13-FEB-2009 was vaccinated with the first 0.5 ml dose of GARDASIL.  At the same visit the patient was vaccinated with the second dose of VARIVAX.  No additional information was provided for the first dose of VARIVAX.  Concomitant vaccine included diphtheria toxoid/tetanus toxoid.  After receiving the first dose of GARDASIL the patient fainted and got injured on her head.  CAT scan has been performed.  The patient recovered on unspecified dates.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Headache, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in July 2008, was vaccinated with the first dose of GARDASIL.  Concomitant therapy included FLONASE and PROVENTIL.  After getting the first dose (onset date reported as January 2009), the patient experienced pain in hands, stomach ache and headache.  Magnetic resonance imaging (MRI) was performed but the result was unknown.  At the time of reporting, the patient's pain in hands and stomach ache and headache persisted.  The patient will not be taking the second and the third dose of GARDASIL.  Additional information has been requested.  5/27/09 Received vaccine & PCP medical records of 1/22-2/17/2009. Records reveal patient experienced tremor of both hands x 2 wks when seen on 1/22.  Neuro exam WNL.  Tx w/meds.  RTC 2/17 w/right wrist pain, tx w/splint & ice. No further records available.  5/29/09 Neurological consult records recieved DOS 1/29/09 to 2/19/09. FINAL DIAGNOSIS: None Provided. Post vaccination intermittent shaking of hands. Headaches. 'Dry heaves' stomach pains.   6/1/09 Received Neuro consult records of 3/9/09. FINAL DX: accentuated physiologic tremor; cervical myofascial pain w/intermittent occipital neuralgia; muscle tension-contraction cephalgia w/vascular overlap.  Tx w/meds & referred back to PCP.
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Exercise tolerance decreased
Clinical narrative: Information has been received from a consumer via internet concerning a female who on an unspecified date was vaccinated with GARDASIL (lot number, injection site and route not reported).  It was reported that the patient was offered a college scholarship for her athletic skills in track and field, and "now can barely run 50 yards without resorting to use an inhaler."  The patient used a nebulizer every couple of hours as she could barely breathe.  It was unknown if the patient sought any medical attention.  The outcome of the patient's experience was unknown.   Attempts are being made to verify the existence of an identifiable patient and reporter.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pain, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 17 year old female with no medical history and drug allergy who on 26-NOV-2008 was vaccinated with her first 0.5 ml dose of GARDASIL (lot # 660391/0063X).  Concomitant therapy included Flu shot.  The patient experienced dizziness, pain and nausea after getting the first dose of vaccine.  It was also reported that after getting the second dose of GARDASIL (lot # 660391/0063X) on 02-FEB-2009 the patient experienced dizziness, pain, nausea and vomiting.  The patient recovered on an unspecified date.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inflammation, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient who on an unspecified date was vaccinated with the third dose of GARDASIL (lot # not reported).  1 1/2 weeks later the patient developed an abnormal Pap smear showing "inflammation" and a positive test for HPV (type not specified).  At the time of reporting, the outcome was unknown.  Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no medical history and drug allergies who was vaccinated with three doses of GARDASIL (lot number unavailable) on unspecified dates.  There was no concomitant medication.  One month ago the patient experienced a rash around her eyes.  At time of reporting, the patient did not recover.  The patient was seen by her eye doctor for medical attention.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Ultrasound Doppler abnormal, Ultrasound antenatal screen
Clinical narrative: Information has been received from a physician for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with no medical history and drug allergies who on 25-AUG-2008 was vaccinated with her second dose of GARDASIL.  There  was no concomitant medication.  Subsequently the patient was pregnant and her LMP was 18-AUG-2008.  She had a fetal ultrasound showing possible unspecified fetal abnormalities.  Lab diagnostics studies included unspecified blood test and fetal ultrasound.  The patient had an office visit for medical attention.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from a Medical Assistant concerning a 17 year old female who 12 weeks ago was vaccinated with the first dose of GARDASIL.  On 17-FEB-2009 the patient learned she was pregnant.  The patient came to the clinic.  Type of pregnancy test that was conducted to patient was unknown.  At the time of reporting, the patient was fine.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL.  Awhile back the patient fainted after vaccination.  The patient was seen at the office.  On unspecified date, the patient recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 20-NOV-2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  Within two weeks after receiving GARDASIL (lot #661764/0650X), the patient experienced nausea and vomiting.  The patient's mother stated that her daughter will not receive the other 2 doses of GARDASIL.  About two weeks after being vaccinated, the patient recovered.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Back pain, Headache, Vomiting
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 16 year old female with a history of asthma and amoxicillin allergy who on 16-FEB-2009 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot # 661766/0652X).  There was no concomitant medication.  On 16-FEB-2009 the patient experienced the onset of vomiting, headache, abdominal and back pain a few hours after receiving the vaccine.  The patient's mother called the office on 17-FEB-2009 and was suggested to give the patient MOTRIN and fluid replacement.  At the time of reporting the patient was recovering.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning her daughter with a history of RSV (respiratory syncytial virus infection) as a child who was vaccinated with the first 0.5 ml dose of GARDASIL.  Subsequently the patient experienced asthma.  On February 5th (year not specified) the patient received the second 0.5 ml dose of GARDASIL.  It made the patient's asthma worse.  At the time of reporting, the outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lethargy
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with GARDASIL 0.5 mL IM.  Subsequently, the patient became "lethargic" after getting GARDASIL.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with a 0.5 ml dose of GARDASIL about a year ago.  The patient has been chronically ill for a year since receiving GARDASIL and was hospitalized 4 times.  The patient's outcome was unknown at time of reporting.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with drug allergies to codeine and IMITREX and no other pertinent medical history who on approximately 12-AUG-2008 ("6 months ago") was vaccinated with the first dose of GARDASIL.  Then the patient received the second dose of GARDASIL and when she had her menstrual cycle.  After that on 17-JAN-2009 ("26 days ago") the patient experienced a migraine.  On 11-FEB-2009 the patient received the third dose of GARDASIL.  There was no concomitant medication.  The patient also happened to start her cycle again and experienced another migraine.  The patient started her menstrual cycle when she was eight year old and she had never had migraines before.  No lab diagnostics studies were performed.  The patient's migraine persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning her daughter who on an unreported date was vaccinated IM with the second dose of GARDASIL.  It was reported that the patient experienced fainting spells "in the months following her second dose of GARDASIL".  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient with no pertinent medical history, no drug reactions/allergies, who on 04-FEB-2009 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (Lot # 661952/1129X).  There was no concomitant medication.  On 09-FEB-2009 the patient experienced hives.  The presentation of the hives limited to the GARDASIL vaccine injection site.  The patient called the practice.  There were no laboratory or diagnostic tests performed.  On 10-FEB-2009, the patient had recovered.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 15 year old female patient with no pertinent medical history and no know drug allergies, who on 26-JUN-2008 was vaccinated with the first dose of GARDASIL (lot# 660391/0063X) 0.5ml intramuscularly.  There was no concomitant medication.  Subsequently the patient experienced insomnia that lasted for a period of three weeks.  Patient was seen at the practice.  No lab diagnostic studies performed.  At the time of this report the patient had recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Syncope, Tinnitus
Clinical narrative: Information has been received from a physician concerning his granddaughter (a 15 year old female) with a family history of allergies who was vaccinated with the first dose of GARDASIL in the "last couple of weeks" (approximately January 2009) and had a severe reaction.  The granddaughter was in the physician's office and collapsed.  The granddaughter had a red face and ringing of unspecified ear.  The patient recovered on an unknown date.  The patient sought medical attention.  No additional information was available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning his 22 year old daughter with no pertinent medical history and no known drug allergies who was vaccinated with all 3 doses of GARDASIL (lot numbers not reported) 0.5ml intramuscularly.  Concomitant therapy included hormonal contraceptives (unspecified).  Patient had a PAP test done on 22-MAY-2006 which was negative and on 19-DEC-2008 patient had a PAP test that revealed that she had mild cervical dysplasia.  Physician reported that he did not have the dates of administration but said that his daughter finished GARDASIL series a year before she had the abnormal PAP test.  Patient sought unspecified medical assistance.  At the time of this report patient had not yet recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Smear cervix abnormal
Clinical narrative: Information has been received from a patient with positive history of papilloma viral (HPV) who on 22-SEP-2008 and 08-DEC-2008 was vaccinated with the 1st and 2nd doses of GARDASIL respectively.  She also had abnormal cells and genital warts before she was given GARDASIL.  Subsequently her abnormal cervical cells had "gotten worse" and she believed it might have caused an "outbreak" of genital warts.  The patient did not want to get the third dose of GARDASIL.  At time of reporting, the patient did not recover.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 25-JAN-2009 was vaccinated with a first dose of GARDASIL 0.5 mL.  In February 2009 ("2 weeks later after getting the vaccine"), the patient experienced joint pain in ankle, legs and wrists.  The patient sought unspecified medical attention.  At the time of reporting, the patient's joint pain in ankle, legs and wrists persisted.  No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Alopecia areata, Antinuclear antibody negative, Blood thyroid stimulating hormone normal, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 21 year old female with attention deficit/hyperactivity disorder and a history of depression who in January 2007, was vaccinated with a first dose of GARDASIL.  The physician stated the patient received three doses of GARDASIL but the dates of administration of the second and third dose were unknown.  Concomitant therapy included CELEXA and ADDERALL tablets.  In February 2007, the patient developed hair loss.  On unknown date, the patient visited the office.  In January 2009, the patient was examined and was diagnosed with alopecia areata.  The patient was prescribed topical steroids and unspecified pulse systemic steroid therapy.  The patient has noticed slight improvement in the symptoms.  The physician added that thyroid levels, antinuclear antibody, sed rate, complete blood count, and comprehensive metabolic panel results were normal.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Metabolic function test, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 21 year old female with attention deficit/hyperactivity disorder and a history of depression who in January 2007, was vaccinated with a first dose of GARDASIL.  The physician stated the patient received three doses of GARDASIL but the dates of administration of the second and third dose were unknown.  Concomitant therapy included CELEXA and ADDERALL tablets.  In February 2007, the patient developed hair loss.  On unknown date, the patient visited the office.  In January 2009, the patient was examined and was diagnosed with alopecia areata.  The patient was prescribed topical steroids and unspecified pulse systemic steroid therapy.  The patient has noticed slight improvement in the symptoms.  The physician added that thyroid levels, antinuclear antibody, sed rate, complete blood count, and comprehensive metabolic panel results were normal.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Muscle twitching
Clinical narrative: Information has been received from a nurse concerning a female patient who in "August 2008" was vaccinated with the second 0.5 ml dose of GARDASIL.  In "October 2008" the patient experienced bad muscle twitching.  No lot number was provided.  It was reported that therapy with GARDASIL was discontinued in "beginning of February 2009".  The patient recovered from muscle twitching on an unspecified date.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Immediate post-injection reaction, No reaction on previous exposure to drug, Vision blurred
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her daughter, a 14 year old female who was vaccinated with a second dose of GARDASIL (lot # not reported).  Subsequently the patient experienced severe blurred vision and a headache immediately after the vaccination.  The patient sought unspecified medical attention.  The patient recovered 12 hours after dose was give.  It was reported that the patient did not have any adverse reactions after the first dose of GARDASIL.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female with no pertinent medical History and no known drug reactions/ allergies, who was vaccinated with the second dose of GARDASIL.  The nurse practitioner reported that on 02-FEB-2009 the patient experienced migraine headache after receiving the second dose of GARDASIL.  Subsequently, the patient recovered from migraine.  The patient sought medical attention and was seen at the practice.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, No reaction on previous exposure to drug, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient who on 04-FEB-2009 was vaccinated with the third 0.5 ml dose of GARDASIL (Lot # 661952/1129X).  On 05-FEB-2009 the patient developed headache, body ache and fever up to 101 degrees.  It was reported that the patient did not have any adverse effects after first dose of GARDASIL received on 3-JUL-2008 and second dose of GARDASIL vaccine, given on an unknown date.  The patient sought unspecified medical attention.  The patient had recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of GARDASIL.  The patient had been hospitalized four times after receiving GARDASIL.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who in approximately 2008 ("about a year ago") was vaccinated with the first dose of GARDASIL at a different physician's office.  In approximately 2008 ("after receiving the first dose") the patient had experienced nausea and dizziness for about 24 hours post vaccination.  Subsequently, the patient recovered.  The patient sought medical attention via seeing physician.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a 16 year old female with a history of irregular periods who has not had her period since receiving her first dose of GARDASIL in August 2008.  She received her second dose in October 2008 but has not yet received her third dose.  Lot number was not available.  At the time of reporting the patient was not recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a consumer concerning his girlfriend with no medical history or drug allergy who on 22-JAN-2009 was vaccinated with the first dose of GARDASIL, 0.5ml.  There was no concomitant medication.  Subsequently the patient developed redness and itchiness at the injection site.  The patient did not perform any lab diagnostics study.  At the time of the report the patient was recovered.  The patient did not seek medical attention.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Injection site vesicles, Rash
Clinical narrative: Information has been received from a medical assistant concerning a female with AUGMENTIN allergy who on 22-JAN-2009 was vaccinated with the third dose of GARDASIL (lot # 661766/0652X).  The patient developed a rash after her third dose of vaccine.  The rash included blisters at injection site, rash from her mid forearm to her neck line on the injection arm and rash on her chest and back.  BENADRYL had been prescribed.  The patient received her first (lot # 660555/0279X) and second (lot # 661530/0575X) dose of GARDASIL on 01-JUL-2008 and 10-SEP-2008 respectively.  At the time of reporting the patient was not recovered.  The patient did not seek medical attention.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site anaesthesia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 31 year old female who on 06-FEB-2009 was vaccinated intramuscularly in the left arm with her first 0.5 ml dose of GARDASIL (661046/0546X).  Concomitant therapy included YASMIN, TOPAMAX, WELLBUTRIN, ALLI, aspirin and vitamins.  On 06-FEB-2009 the patient developed pain in her injection arm after her initial dose of vaccine.  The pain has persisted at the same intensity since then.  The arm was not warm, not swollen, and not red.  The pain was from the neck to below the elbow and at the time of reporting was from the shoulder to the elbow.  The pain has been described as "feeling like she has been working too long at the computer."  The patient also experienced numbness in the left arm the night of 09-FEB-2009 which resolved the morning of 10-FEB-2009.  She has treated the pain with TYLENOL, aspirin, heat, and BEN GAY with no relief.  Patient is considering not completing the series because of this reaction.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Condition aggravated
Clinical narrative: Information has been received from a case in litigation for WAES # 0902USA01678 from a consumer who reported "her daughter's anemia became worse after received a dose of GARDASIL."  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Migraine, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient who on 08-JAN-2007 was vaccinated with the first dose of GARDASIL (lot # 655619/1427F) 0.5 ml intramuscularly.  On 22-JAN-2008 the patient received her second dose of GARDASIL (lot # 659657/1487U) 0.5 ml intramuscularly.  On 08-JAN-2007 the patient experienced migraine headaches after the first dose.  After the second dose, the patient experienced migraine headaches again.  The patient also had the first two shots over a year apart.  As of 11-FEB-2009, the patient had not received the third dose.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not specified), intramuscularly.  The patient experienced muscle pain, weakness and fatigue after receiving the GARDASIL vaccine.  The physician indicated that the patient was planning report the events.  The patient sought unspecified medical attention and underwent unspecified tests by a rheumatologist.  At the time of reporting, the outcome of the event is unknown.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Bladder disorder, Enuresis
Clinical narrative: Information has been received from a Nurse practitioner (N.P.) concerning a 15 year old female who on 01-OCT-2008 was vaccinated with a 0.5 ml dose of GARDASIL (lot # 0947X).  01-OCT-2008 the patient experienced uncontrollable bladder symptoms and wet the bed overnight after receiving the vaccine.  The patient recovered 24 hours after receiving the vaccine.  It was reported that therapy with GARDASIL was discontinued on 01-OCT-2008.  The patient sought unspecified medical attention.  Additional information has been requested. Follow up information was received from an other health professional concerning the 15 year old female patient with sports induced asthma who on 10-JAN-2008 at approximately 1;00 pm was vaccinated in the left arm with he rfirst dose of GARDASIL. At the night of injection, the patient had uncontrollable bladder. She peed the bed and severe frequency that lasted into the next evening. The syndromes lasted approximately 24 hours. The patient was recovered 24 hours later (02-OCT-2008). Her mother confirmed the adverse event. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage, Pregnancy test positive
Clinical narrative: Information has been received from a female , for GARDASIL who in December 2008, was vaccinated with GARDASIL (number in series not reported). Two days later the patient started to bleed for two weeks. The consumer reported she just took two home pregnancy test and both came out positive, but she was scheduled to go to see her physician this week to find out if she really was pregnant. No further information is available.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Hypotension, Syncope
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with no known medical history, who on 29-DEC-2008 was vaccinated with a second dose of GARDASIL (lot # 661044/0548X), intramuscularly in the right arm at 16:45. Concomitant therapy included a second dose HAVRIX (lot # AHAVB319AA), intramuscularly in the left arm on 29-DEC-2009 at 16:45. On 29-DEC-2008 the patient received the GARDASIL vaccine in the right arm and HAVRIX in the left arm. The patient fainted but regained conscience immediately. After taking vital signs, the patients blood pressure was low. The patient was monitored until the blood pressure came up in about 15 minutes. The patient recovered on 29-DEC-2008. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female student (weight 134.8 pounds, height 65.5 inches) who on the afternoon of 02-FEB-2009 was vaccinated with the third dose of GARDASIL, intramuscularly in the arm. Concomitant suspect therapy included VAQTA. On 02-FEB-2009 the patient had a syncopal episode few minutes after receive the GARDASIL vaccine in the waiting room. The patient recovered immediately from syncope but had to lay for approximately 30 minutes. Syncopal episode was considered to be an other important medical event by the physician. Additional information is not expected.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Blood immunoglobulin E increased, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 15 year old patient who on 14-JAN-2009 was vaccinated with the first dose of GARDASIL.  Subsequently the patient experienced significant swelling of the upper arm.  Approximately a six inch region of the upper arm swelled to double the normal size following the administration of the vaccine.  The patient was tested and the physician found significantly elevated level of immunoglobulin E (IGE).  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a health professional concerning a 15 year old female with no allergies who on an unspecified date was vaccinated with an "injection in the arm" (unspecified) of GARDASIL (lot number not available).  The patient broke out with a rash at the injection site after receiving her first dose of GARDASIL.  The onset was noted as one day after the vaccination.  Unspecified medical attention was sought.  The rash lasted for 2-3 weeks.  Subsequently, the patient recovered from rash at injection site 2-3 weeks after vaccination.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia, Vaginal haemorrhage
Clinical narrative: Information has been received from a nurse practitioner concerning her sister who was vaccinated with a first dose of GARDASIL in arm.  On unknown date the patient experienced breakthrough bleeding and spotting.  On unspecified date, the patient recovered from breakthrough bleeding and spotting.  The patient sought unspecified medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Formication, Smear cervix abnormal, Vaginal haemorrhage
Clinical narrative: Information has been received from a 29 year old female consumer who in April 2008, was vaccinated with the first dose of GARDASIL.  On June 2008, the patient received the second dose of GARDASIL.  After receiving the second dose the patient began to experience abnormal vaginal bleeding, abnormal pap smears and the feeling of "bugs crawling on her skin".  The symptoms had persisted since the second dose was administered.  The patient called her physician office, but had not spoken with them yet.  Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hair growth abnormal, Smear cervix abnormal, Vaginal disorder
Clinical narrative: Information has been received from a 29 year old female consumer who in April 2008, was vaccinated with the first dose of GARDASIL.  On June 2008, the patient received the second dose of GARDASIL.  After receiving the second dose the patient began to experience abnormal vaginal bleeding, abnormal pap smears and the feeling of "bugs crawling on her skin".  The symptoms had persisted since the second dose was administered.  The patient called her physician office, but had not spoken with them yet.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Formication, Smear cervix abnormal, Vaginal haemorrhage
Clinical narrative: Information has been received from a 29 year old female consumer who was vaccinated on an unspecified date with the second dose of GARDASIL 0.5 ml intramuscularly. The patient reported that the vaccine "really tore [her] whole body up" as it "ruptured in her vagina", she had an abnormal pap smear and it stopped her hair from growing. The patient sought unspecified medical attention. Additional information has been requested.