chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old female who in approximately August 2008, 2 months ago, was vaccinated with GARDASIL as her first dose. Subsequently the patient experienced a fever for 2 days. She also had not had a menstrual period since she received the dose 2 months ago and in the past week she had been vomiting and nauseous. The patient had not recovered. It was confirmed that the patient was not pregnant. The patient had not sought medical attention. Physician can be contacted. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 18 year old female patient with penicillin allergy who was vaccinated on unspecified dates with a first and second dose of GARDASIL. There was no concomitant medication. The patient experienced a rash under her fingernails the day after receiving the second dose. The patient sought medical attention. She was seen at the hospital on 1-Oct-2008 and a complete blood count with differential was normal. But the symptom persisted. The reporter felt that a rash under her fingernails was related to therapy with GARDASIL. No additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a female who on 06-OCT-2008 was vaccinated with the first dose GARDASIL in her arm, and immediately post vaccination she had redness and swelling at the injection site. The patient was treated with ice and medication, unknown name of medication and unspecified if medication was oral or topical. The patient was recovering. The patient sought medical attention at the office. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Guillain-Barre syndrome, Metabolic function test, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient, who in approximately July 2008, was vaccinated with the third dose of GARDASIL. Recently, the patient experienced GUILLAIN-BARRE SYNDROME and was hospitalized. The patient sought medical attention via ER visit. Additional information has been requested.  2/18/09 Received hospital medical records of 9/22-9/27/2008. FINAL DX: cardiogenic syncope & migraines Records reveal patient experienced tingling of bilateral LEs & 1 arm that progressed to face/throat lasting approx 15 min while in school, with dizziness, lightheadedness when standing from sitting, visual disturbance & difficulty walking x 3 days.  Had been seen in ER on 9/22, w/u WNL & released  Eval by PCP & sent to hospital as direct admit.   Neuro & cardio consults.  Exam revealed decreased DTRs.  LP done. This is in follow-up to report9s) previously submitted on 11/14/2008.  Follow-up information was received that the patient with no pertinent medical history and no known drug allergies on 10-JUL-2007 was vaccinated with the first dose of GARDASIL (lot # 657621/0387U), and on 08-OCT-2007 she received the second dose of GARDASIL (lot # 658558/1061U).  On 16-MAY-2008, the patient was vaccinated with the third dose of GARDASIL (LOT # 660391/0063X) IM into her left arm.  There was not concomitant medications given with the third dose.  On 15-SEP-2008, the patient experienced guillain-barre syndrome.  The patient was seen in the office on 22-SEP-2008.  During confinement, the patient had a normal EKG and normal blood work;  the patient also had a "successful" lumbar puncture on 25-SEP-2008 (no result provided).  The patient was discharged on 26-SEP-2008 on FLORINEF prescribed by neurologist.  The patient was seen in the office on 30-SEP-2008 and she stated that she had back pain from the lumbar puncture.  As of 03-OCT-2008 the patient was recovering.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Immediate post-injection reaction, Injection site oedema, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a 21 year old female, weight 190, high 5'7" with no drug reactions or allergies, a history of migraine, who on 06-Oct-2008 10:30AM was vaccinated with the first dose of GARDASIL (intramuscular, lot # 661044/C548X) at right deltoid at private doctor's hospital. Concomitant therapy included Butisol, YASMIN 28, fexofenadine. On 06-Oct-2008 10:30AM, immediately after withdrawing the syringe, the patient's arm turned red and the redness spread down the arm and became swollen. Ice was applied and the patient was given a prescription for Benadryl and Prednisone. The patient sought medical attention at office. No further information was reported. Follow up information was received: Patient had side effects of erythema and mild edema of the injection site extending to lower right arm. Patient was given Zantac, Prednisone and Benadryl: On 09-Oct-2008, the patient's swelling was better. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a 22 year old female who experienced abdominal pain prior to receiving her second dose of GARDASIL (Lot # was not reported). The date of the abdominal pain began was not specified by the reporter. The patient sought medical attention in physician's  office. The outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pain, Rash
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter, who on 03-OCT-2008, was vaccinated with the second dose of GARDASIL, 0.5 ml, intramuscular. The patient was fine and had no pain and no side effect after receiving the first dose of GARDASIL on an unspecified date. By the evening of 03-OCT-2008, the patient experienced pain. The patient complained it hurt a lot. On 05-OCT-2008, the patient developed rash over forehead and spread into hairline to scalp. The mother would alert a physician to examine and assess the patient. This is one of two sibling reports from the same source. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on approximately 03-OCT-2008 was vaccinated with the second dose of GARDASIL. On 03-OCT-2008, about 6 hours after the vaccination, the patient complained pain and experienced rash started on face and then rash all over the face. On 05-OCT-2008 the patient experienced injection site hard swollen, red, warmth to touch and injection site knot. However after the first dose of vaccination, the patient was fine, no pain and adverse event occurred. The mother of the patient informed the doctor about the event and wanted to have her daughters examined, then she called MNSC. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on approximately 03-OCT-2008 was vaccinated with the second dose of GARDASIL. On 03-OCT-2008, about 6 hours after the vaccination, the patient complained pain and experienced rash started on face and then rash all over the face. On 05-OCT-2008 the patient experienced injection site hard swollen, red, warmth to touch and injection site knot. However after the first dose of vaccination, the patient was fine, no pain and adverse event occurred. The mother of the patient informed the doctor about the event and wanted to have her daughters examined, then she called MNSC. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 25 or 26 year old female who was vaccinated IM with GARDASIL vaccine.  Subsequently that patient experienced abnormal Pap test with high risk human papillomavirus (HPV) "after completing the series" of GARDASIL.  The patient sought medical attention: office visit.  No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 06-OCT-2008 was vaccinated with GARDASIL as her first dose.  Subsequently the patient experienced nausea, dizziness and sweating 5-10 minutes after receiving the 1st dose of GARDASIL.  The patient lay down for 30 minutes at the office and got better.  The patient sought medical attention at the office.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Amenorrhoea, Syncope, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: Information has been received from patient's grandmother concerning her 15 year old granddaughter who was vaccinated IM with the first dose of GARDASIL (lot number not reported).  The patient experienced weight loss, hair loss, cessation of menstrual cycles, and several episodes of fainting after being vaccinated with GARDASIL.  The patient was recently diagnosed with type 1 diabetes.  The patient's type 1 diabetes persisted.  The patient's grandmother did not have physician's information or specified dates.  No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 21 year old female with a history of anxiety and depression who was vaccinated intramuscularly with a first and second dose of GARDASIL (Lot # 0250X) on 04-JUN-2008 and an unknown date respectively. Subsequently, the patient experienced pain in back and in both arms about 2 weeks after each dose. Unspecified medical attention was sought; no laboratory or diagnostic tests were performed. The patient recovered from pain in back and pain in both arms each time. Additional information has been requested
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody negative, Blood creatine phosphokinase normal, Borrelia burgdorferi serology negative, Epstein-Barr virus test negative, Fatigue
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no medical history and no known drug allergies who on 27-AUG-2008 was vaccinated with a first 0.5ml dose of GARDASIL intramuscularly.  Concomitant therapy included topical clindamycin.  The patient experienced myalgia in calves, lower thigh, back and neck after the vaccination in 10-SEP-2008-17-SEP-2008.  She also is experiencing fatigue.  Medical attention was sought, the patient was seen in the office.  Laboratory tests were performed, all of following were negative: lyme panel, CPK level, antinuclear antibody, rheumatoid factor, mononucleosis, sedimentation rate 2, CBC.  The patient has not recovered at the time of report.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Myalgia, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no medical history and no known drug allergies who on 27-AUG-2008 was vaccinated with a first 0.5ml dose of GARDASIL intramuscularly.  Concomitant therapy included topical clindamycin.  The patient experienced myalgia in calves, lower thigh, back and neck after the vaccination in 10-SEP-2008-17-SEP-2008.  She also is experiencing fatigue.  Medical attention was sought, the patient was seen in the office.  Laboratory tests were performed, all of following were negative: lyme panel, CPK level, antinuclear antibody, rheumatoid factor, mononucleosis, sedimentation rate 2, CBC.  The patient has not recovered at the time of report.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning an 18 year old female, who approximately 30-SEP-2008, was vaccinated with a third dose of GARDASIL (lot# was not reported). 24 hours after vaccination, the patient experienced abdominal cramping, which was not recovered at the of reporting. Nurse and physician do not think abdominal cramp is vaccine related. An office visit is scheduled. Additional information has been requested. Follow-up information was scheduled. Follow-up information was received from a licensed practial nurse (L.P.N). The patient experienced cramping on 7-OCT-2008 and her outcome was unknown. Follow-up information was received from the licensed practial nurse (L.PN.). The patient exerienced cramping on 7-OCT-2008 and her outcome was unknown. Follow-up information was received from the licensed practial nurse (L.PN.). It was reported that the patient was a female stundent with no more problems at time of vaccination who was vaccinated IM into arm with a first and second dose of GARDASIL (lot #661046/0381X) on 18-MAR-2008 and 30-SEP-2008, respectively. Subsequently, the patient experienced abdominal cramping on 30-SEP-2008. The patient recovered on an unspecified date. Follow-up information was received from the licensed practial nurse (L.P.N).  It was reported that the patient was vaccinated with a first, second and third dose of GARDASIL. (lot #661046/0381X for P1 and P3. lot #unknown for P2) on 18-MAR-2008. 01-JUL-2008 and 30-SEP-2008 and 7-OCT-2008. Reporter stated that the patient was never hospitalized and now considered fully recovered. No further information is available.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a healthcare professional concerning her niece of 10 year old who on 03-OCT-2008, was vaccinated with the first dose of GARDASIL vaccine.  The healthcare professional reported that on 03-OCT-2008, her niece had experienced hives after receiving the first dose of GARDASIL vaccine.  On unspecified date the patient had recovered.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Streptococcal identification test negative, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female. On 22-JUL-2008, she was vaccinated with a first dose of GARDASIL IM into the right deltoid. On 06-OCT-2008, she was vaccinated with a second dose of GARDASIL vaccine IM into the right deltoid. In the morning of 07-OCT-2008, the patient went to urgent care center with complaints of fever, nausea, and vomiting. The patient's temperature was 100.6 F as taken by tympanic thermometer. she was given a strep throat test, with negative result. The patient was released form urgent care center. Treatment was over the counter TYLENOL or Ibuprofen as needed. She had follow up appointment with nurse practitioner. The patient's fever, nausea, and vomiting persisted. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Bronchitis, Cough, Erythema, Headache
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with penicillin allergy, asthma and some allergies who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL and with the second dose on 04-Oct-2007. Concomitant therapy included FLOVENT, Albuterol and a prescription drug cough medicine. On 21-JUL-2007 the patient experienced itchiness, redness and swelling of hands and feet. On 05-OCT-2007, after second vaccination the patient experienced hives all around both knees with causes itching and redness. The hives subsequently spread to  her feet, and then to her entired body including her face. The patient subsequently developed bronchitis, felt weak all the time and had "never ending headaches". At the time of report, the patient was doing better but she had "no stamina" and she continued to experience coughing spasms and brochitis periodically.  Also, whenever her extremities, such as her hand or feet are subjected to coldness or cold temperatures, they turn red and she experienced itchness. The patient was recovering. No additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Peripheral coldness, Pruritus, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with penicillin allergy, asthma and some allergies who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL and with the second dose on 04-Oct-2007. Concomitant therapy included FLOVENT, Albuterol and a prescription drug cough medicine. On 21-JUL-2007 the patient experienced itchiness, redness and swelling of hands and feet. On 05-OCT-2007, after second vaccination the patient experienced hives all around both knees with causes itching and redness. The hives subsequently spread to  her feet, and then to her entired body including her face. The patient subsequently developed bronchitis, felt weak all the time and had "never ending headaches". At the time of report, the patient was doing better but she had "no stamina" and she continued to experience coughing spasms and brochitis periodically.  Also, whenever her extremities, such as her hand or feet are subjected to coldness or cold temperatures, they turn red and she experienced itchness. The patient was recovering. No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Diarrhoea, Dizziness, Headache, Malaise
Clinical narrative: Information has been received from a nurse concerning a female patient with no known allergies and no pertinent medical history who on 02-OCT-2008 was vaccinated with the first and only dose of GARDASIL 0.5 ml, IM.  There was no concomitant medication.  On 02-OCT-2008 after receiving the vaccine, the patient was not feeling well, felt dizzy and experienced headaches.  The patient searched on the web site for GARDASIL adverse event symptoms and she realized that she had similar symptoms.  The patient complained of diarrhoea, jaw pain, leg aches and anxiety.  The patient went to emergency room and was released.  No laboratory test were performed.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: Information has been received from a nurse concerning a female patient with no known allergies and no pertinent medical history who on 02-OCT-2008 was vaccinated with the first and only dose of GARDASIL 0.5 ml, IM.  There was no concomitant medication.  On 02-OCT-2008 after receiving the vaccine, the patient was not feeling well, felt dizzy and experienced headaches.  The patient searched on the web site for GARDASIL adverse event symptoms and she realized that she had similar symptoms.  The patient complained of diarrhoea, jaw pain, leg aches and anxiety.  The patient went to emergency room and was released.  No laboratory test were performed.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Vertigo
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old female consumer with no allergy or medical history who on 07-AUG-2008 at 13:00 was vaccinated with her first dose of GARDASIL vaccine (LOT# 660557/0072X), 0.5ml, IM on her left arm.  There was no concomitant medications.  Subsequently on approximately 11-AUG-2008 the patient experienced vertigo, and "it was so bad that she had to hold onto the wall for support".  Medical attention was not sought.  And three days later, on 14-AUG-2008 the patient recovered without treatment.  On 07-OCT-2008 the patient arrived in the doctor's office for her second dose of GARDASIL vaccine.  No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a female patient. In February 2008, she was vaccinated with the first dose of GARDASIL. On 29-SEP-2008, she was vaccinated with the second dose of GARDASIL. After getting the second dose of GARDASIL the patient experienced pain at the injection site. No additional information expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Headache, Influenza like illness, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old Caucasian female with reaction to codeine (nausea and vomiting) and had no illness at the time of vaccination who on 06-OCT-2008 was vaccinated with her first dose of GARDASIL vaccine (lot number 661703/0651X) 0.5ml IM into deltoid.  Concomitant therapy included MICRONOR.  On 07-OCT-2008 the patient woke the day after the vaccination feeling nauseas and had flu-like symptoms.  As the day went on, nausea increased.  The patient developed mild headache.  By 5pm, the patient felt mild to severe nausea, chilly, headache.  Symptoms entirely gone by 08-OCT-2008.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning three females who were vaccinated with a dose of GARDASIL on an unspecified date. The patient did not have HPV before receiving GARDASIL. After receiving GARDASIL, the patient had positive results of HPV. At the time of report, the outcome was unknown. The patient sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Headache, Migraine, Nausea
Clinical narrative: Information has been received form a registered nurse concerning a 19 year old female with a history of migraine who on 28-JUL-2008 and 06-SEP-2008 was vaccinated with a first and second dose of GARDASIL (Lot # was not reported) intramuscularly in the deltoid. Concomitant therapy included YASMIN. Subsequently, the patient experienced dizziness, "weakness all over", nausea, and a headache led to a migraine about 24 hours after the second dose of vaccination. The patient sought medical attention via a telephone call. No laboratory or diagnostic tests were performed. On an unspecified date the patient reported the nausea subsided but weakness and headache persisted. The patient was instructed to call back if symptoms did not resolve.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Acarodermatitis, Blister, Erythema, Pruritus, Weight increased
Clinical narrative: Information has been received from a physician concerning a 13 year old female who is daughter of a nurse.  The patient was with seasonal allergy and no drug reactions/allergies and a history of anaemia as an infant.  On 02-MAY-2008 the patient was vaccinated with her first dose of GARDASIL vaccine and on 23-JUL-2008 her second dose.  Concomitant therapy included CLARINEX, VISTARIL and DIPROLENE.  The patient experienced itching in the left arm "about 1-2 weeks after the first injection".  The family physician treated the patient's symptoms with ZYRTEC; however, the patient's symptoms did not improve.  A dermatology specialist diagnosed and treated the patient for scabies (treatment Unspecified).  The patient's rash was described as intermitted with red spots on the abdomen and breasts.  Raised blister like spots developed on the palms of the patient's hands by the end of August, 2008 (date unspecified.)  The family physician prescribed MEDROL DOSEPAK and the symptoms resolved until the dose pack was completed.  The patient was currently prescribed an unspecified dose of prednisone.  The patient gained 14 pounds since beginning the methylprednisolone on 04-SEP-2008.  The patient was scheduled for an evaluation with another dermatologist on 09-OCT-2008.  No other symptoms and treatment reported.  No other information available.  The patient had not recovered from the adverse events at the time of the report.  Lab diagnostics studies performed included blood work (complete blood count, liver function studies).  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Anaemia
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with allergies to amoxicillin and sulfonamide and no pertinent medical history reported, who in June 2008, was vaccinated with her first dose of GARDASIL. Subsequently the patient experienced hair loss. In August 2008, the patient was vaccinated with her second dose of GARDASIL. The hair loss became worse after the second dose of vaccination and she was "recently" diagnosed with anemia. No further information was given. Concomitant therapy included ALLEGRA. Lab diagnostics studies performed included routine blood work. The patient had not recovered at the time of the report. The patient was seen by a physician. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Rash papular
Clinical narrative: Information has been received from a physician concerning a 23 year old female with egg allergy, who on approximately 24-SEP-2008, was vaccinated with her second 0.5 ml dose of GARDASIL, IM. Subsequently, "within days of the second vaccination", the patient experienced small papules on her body which the physician reported was an allergic reaction. The patient sought medial attention by seeing the physician. No further information is available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a pharmacist concerning a college age female, who on unknown dates, received her first two dose of GARDASIL without adverse symptoms noted, and then in June 2008, was vaccinated with her third dose of GARDASIL, 0.5 ml, therapy route unspecified. Subsequently, the patient developed a 4 cm lump at the injection site, no pain or erythema. The doctor feels it is calcification. Laboratory tests included X-ray, result unspecified. And no treatment has been performed. The patient's lump at the injection site persisted. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a counselor concerning a 21 year old female who was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced a rash. The patient recovered on unspecified date. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pain, Syncope
Clinical narrative: Information has been received from a nurse concerning a 24 year old female, who on 08-OCT-2008, was vaccinated intramuscularly in deltoid with the first dose of GARDASIL (lot# not reported). The patient was sitting in the chair, complained of pain and fainted within 2 minutes of receiving the vaccine. The patient recovered on 08-OCT-2008. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on unspecified date was vaccinated with a first dose of GARDASIL. On 17-JUL-2008 the patient was vaccinated intramuscularly in the right shoulder with a second dose of GARDASIL. Concomitant therapy included MENACTRA which was vaccinated intramuscularly in the left shoulder and ADACEL at the same visit on 17-JUL-2008 at different injection sites. On approximately 20-JUL-2008 the patient experienced generalized rash all over her body. The patient spoke to the physician about the rash. At the time of reporting the patient's generalized rash all over her body persisted. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Aura, Feeling abnormal, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who on 01-OCT-2008 was vaccinated with GARDASIL. There was no concomitant medication. Subsequently, the patient had an injection site reaction "later in the day" following vaccination with GARDASIL that lasted for 24 to 48 hrs. The injection site reaction was described as painful, red injection site. Subsequently, the patient developed a severe headache with aura and felt "dazed" with syncope for about 20 minutes on 08-OCT-2008. The patient had a sore throat and flu like symptoms earlier in the day on 08-OCT-2008, outcome of visit was unspecified.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Oropharyngeal pain, Syncope
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who on 01-OCT-2008 was vaccinated with GARDASIL. There was no concomitant medication. Subsequently, the patient had an injection site reaction "later in the day" following vaccination with GARDASIL that lasted for 24 to 48 hrs. The injection site reaction was described as painful, red injection site. Subsequently, the patient developed a severe headache with aura and felt "dazed" with syncope for about 20 minutes on 08-OCT-2008. The patient had a sore throat and flu like symptoms earlier in the day on 08-OCT-2008, outcome of visit was unspecified.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning an 11 year old female patient. The patient fainted during the administration of the first dose of GARDASIL (dose and route not reported). The nurse reported that the patient received her second and third dose of GARDASIL and did not faint. No other information to report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who couple months ago was vaccinated with the first 0.5ml dose of GARDASIL. Lot number was not provided. Subsequently the patient experienced fainted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Inappropriate schedule of drug administration, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 19 year old female who became sexually active at 16.5 years old and had a normal PAP December 2006. In December 2006 the patient had her first dose of GARDASIL (therapy route, site unknown), second January 2007, and her third March 2007. In August 2008 the patient had an abnormal PAP for high risk HPV. In October 2008 she had a colposcopy (results not provided). At the time of report, the patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cyst, Hypersensitivity, Skin disorder
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with the first dose of GARDASIL (unspecified dose). Subsequently, "shortly after initial dose of GARDASIL", the patient experienced cysts, and marks or her legs, buttocks, and groin areas. The physician felt it may be at allergic reaction to GARDASIL. At the time of the report, the AE did not improved and the patient had not recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner, concerning a 15 year old female who in "summer 2008", which was in approximately July 2008, was vaccinated with the first dose of GARDASIL (total daily dose and route not reported).  An hour after the first dose of GARDASIL, the patient developed a mild fever of 102F (also reported as the patient was "warm" and fever temperature was not determined).  An hour after the fever started the patient developed a severe headache and dizziness lasting 24 hours and the patient was unable to go to school.  At the time of the report, the patient recovered from mild fever, severe headache and dizziness.  It is not known if the patient sought medical attention.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Hypoaesthesia, Laboratory test, Pregnancy test negative
Clinical narrative: Information has been received from a registered nurse concerning a female with obesity and no drug reactions/allergies who was vaccinated with GARDASIL vaccine, 0.5 milliliter intramuscular, in May and in July of 2008.  In September 2008, the patient experienced bilateral numbness in her arms.  The patient sought medical attention in office.  Additional information has been requested. This is in follow-up to report (s) previously submittedon 11/14/2008. Medical records had been received indicated a female was vaccinated with the first (lot # 659964/1978U), the second (lot # 660553/0070X), left deltoid) and the third  (lot # 661766/0652X), right deltoid dose of GARDASIL on 05-May-2009, 30-Jun-2008 (13:10) and 03-Nov-2008 (09:08) respectively. The patient had eye problems/visual problems and wore glasses. The patient's health was good and had a past medical history of deafness. The patient had a history of unspecified surgery or had been a patient in a hospital. The patient had childhood immunization.The patient took precautions against sexually transmitted infections. The patient's first menstrual period was 12 year old and had heavy periods/cramps. The patient had one pregnancy when she was 22 year old also reported as the patient had one ectopic pregnancy and one miscarriage. The patient had used pill, condoms, sterlization, suppository/film, natural family planning (rythm) and withdrawl birth control methods in the past. Concomitant therapy included green tea and herbal for energy. The patient's blood pressure was 98/34 on 13-Sep-2008. On 10-Sep-2008 the patient complained of bilateral numbness in upper to mid-lower arms though she displayed good dexterity with testing ability of both hands. The patient denied tingling in both hands. The patient thought numbness was due to GARDASIL injection given on 05-May-2008 and 10-Jun-2008. The physician suggested the patient go to urgent care if numbness persisted or increased. The patient returned on 11-Jun-2008 for the third dose of GARDASIL and indicated that her arm was "sore" not numb. No further informatin is available. The VAERS # is 334035.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a 21 year old female who "sometime last week", which was on approximately 29-Sep-2008, was vaccinated with the second dose of GARDASIL. After receiving GARDASIL, the patient fainted then came shortly after, and after fainting, the patient had vomited. At the time of report, the patient fully recovered from faint and vomiting, but the physician reported it was unsure if the patient was going to finish the rest of the series. The patient sought medical attention in the physician's office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female with medical history unspecified who on unspecified date was vaccinated a dose with GARDASIL (Lot # was unspecified). Concomitant therapy was unspecified. Subsequently, the patient experienced fainting. The patient sought unspecified medical attention. The outcome of the AE was unspecified. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL (lot# not provided), 0.5 ml, intramuscular. Concomitant therapy included "VIAVAN". The patient had no medical history or drug allergy. Subsequently, the patient developed 3 welts on her arm where the vaccine was administered. The patient sought medical attention and biopsy of welts was performed. Therapy with human papillomavirus vaccine was discontinued. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Hypoaesthesia, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with allergy to penicillin and all cillins and a history of Lyme disease who in Summer 2007 was vaccinated with her first dose of GARDASIL, IM; second dose in Fall 2007, and third dose in March 2008. Concomitant therapy included ALLEGRA, Montelukast sodium (MSD), PANELOR and ESTROSTEP. Subsequently "soon after receiving 3rd shot" the patient experienced occasional tingling in her hands and feet, and numbness in her arms and legs. Laboratory tests included blood work checked for MS, lupus and other diseases (results not reported), and will have an MRI in November. At the time of this report the patient's symptoms persisted. The patient sought medical attention with the physician. Additional information has been requested.  12/23/08 Reviewed rheumatology eval of 8/19/2008. FINAL DX: arthralgia, muscle spasm Records reveal patient experienced Raynaud's phenomomen of fingers & toes; paresthesias of hands & feet x 3 mo; joint pain hands.  No other medical records available at this time.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood pressure decreased, Condition aggravated, Confusional state, Dizziness, Heart rate decreased
Clinical narrative: Information has been received from a physician concerning a 19-year-old female patient, who on 09-OCT-2008 received a third dose of 0.5 ml GARDASIL (lot # 660618/0572X, injection site not reported) via intramuscular route.  Concomitant vaccination included a dose of FLUZONE (preservative free).  The patient had previously received her first dose of GARDASIL (lot # 658556/1060U), together with a dose of MENACTRA and DTAP on 22-FEB-2008; and her second dose of GARDASIL (lot # 658556/1060U) on 13-APR-2008.  On 09-OCT-2008, within 5 or 10 minutes after administration of the third dose of GARDASIL, the patient reported that she felt dizzy and lightheaded and sunk to the floor.  Loss of consciousness was suspected.  She was very "confused, pale, color poor and limbs cold."  The patient was placed on exam table.  She did not have a palpable pulse; her heart rate was in 40's via stethoscope and her blood pressure was 80/50.  She was diaphoretic.  The patient was given some apple juice and condition monitored.  According to the patient, she had not eaten breakfast.  After given more juice, the patient's heart rate improved and her blood pressure rose to 90/60.  After being observed for a while she was sent home.  The patient also had a similar episode a few weeks ago after running at a track.  On a follow up phone call from the doctor on 10-OCT-2008, the patient was fine.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Peripheral coldness, Pulse absent
Clinical narrative: Information has been received from a physician concerning a 19-year-old female patient, who on 09-OCT-2008 received a third dose of 0.5 ml GARDASIL (lot # 660618/0572X, injection site not reported) via intramuscular route.  Concomitant vaccination included a dose of FLUZONE (preservative free).  The patient had previously received her first dose of GARDASIL (lot # 658556/1060U), together with a dose of MENACTRA and DTAP on 22-FEB-2008; and her second dose of GARDASIL (lot # 658556/1060U) on 13-APR-2008.  On 09-OCT-2008, within 5 or 10 minutes after administration of the third dose of GARDASIL, the patient reported that she felt dizzy and lightheaded and sunk to the floor.  Loss of consciousness was suspected.  She was very "confused, pale, color poor and limbs cold."  The patient was placed on exam table.  She did not have a palpable pulse; her heart rate was in 40's via stethoscope and her blood pressure was 80/50.  She was diaphoretic.  The patient was given some apple juice and condition monitored.  According to the patient, she had not eaten breakfast.  After given more juice, the patient's heart rate improved and her blood pressure rose to 90/60.  After being observed for a while she was sent home.  The patient also had a similar episode a few weeks ago after running at a track.  On a follow up phone call from the doctor on 10-OCT-2008, the patient was fine.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female vaccinated intramuscularly with 3 dose of 0.5 ml GARDASIL. After each dose the patient developed pain from her shoulder to her neck. The patent was seen by a physician in the office. The pain lasted 4 days each time. The outcome is recovered for the first two events of pain and unknown for the last. additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who on 08-OCT-2008 was vaccinated with a dose of GARDASIL vaccine.  The registered pharmacist reported that on 09-OCT-2008, the patient developed a "full body rash" after receiving GARDASIL vaccine.  The patient sought medical attention at an office visit.  At the time of the report the patient had not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2008; 1/7/2009. Follow up information was received from a physician who stated that he remembered the patient but not her name or identification number: "At the time I saw her, her rash was totally normal and clear". He stated that he could not contribute any useful information about the event because he had never seen the rash at all. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Drug administered at inappropriate site, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a nurse on 30-SEP-2008 concerning a 20 year old female with penicillin and sulfa allergies, and a gynecological history of Pap smear in 2005 who was vaccinated with a third dose of GARDASIL by a pharmacy. Subsequently the patient experienced pain in left shoulder, radiates down to the arm, increases with movement, aggravated by sleeping on the same side, weakness, started after vaccination one month ago and has not gotten any better. The patient's family history included both parents' kidney/bladder problems. Assessment of this event was joint pain, shoulder (primary). An X-ray in left shoulder was performed. Follow up information has been received on 02-OCT-2008. It was reported that the patient continued to have pain in it shoulder with ROM and is painful at rest. Medications for the event included ibuprofen 600mg 1 tab (s) QID, VICODIN 500mg-5 mg 1 tab(s) Q4H. Assessment were joint pain, shoulder (primary), and disorder of tendon of shoulder region NOS, left intraspinatus partial tear. A MRI in left shoulder was performed. Follow up information has been received on 10-OCT-2008. It was reported that the patient has pain and difficulty in rotating the arm and difficulty in movement. The nurse and the patient felt had an intrasupra splintus tear due to the injection being given in a tendon rather than the deltoid. At the time of the report, the outcome was unknown. The reporter reported that it believed to be mechanical injury on 20-OCT-2008. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Tendon disorder
Clinical narrative: Information has been received from a nurse on 30-SEP-2008 concerning a 20 year old female with penicillin and sulfa allergies, and a gynecological history of Pap smear in 2005 who was vaccinated with a third dose of GARDASIL by a pharmacy. Subsequently the patient experienced pain in left shoulder, radiates down to the arm, increases with movement, aggravated by sleeping on the same side, weakness, started after vaccination one month ago and has not gotten any better. The patient's family history included both parents' kidney/bladder problems. Assessment of this event was joint pain, shoulder (primary). An X-ray in left shoulder was performed. Follow up information has been received on 02-OCT-2008. It was reported that the patient continued to have pain in it shoulder with ROM and is painful at rest. Medications for the event included ibuprofen 600mg 1 tab (s) QID, VICODIN 500mg-5 mg 1 tab(s) Q4H. Assessment were joint pain, shoulder (primary), and disorder of tendon of shoulder region NOS, left intraspinatus partial tear. A MRI in left shoulder was performed. Follow up information has been received on 10-OCT-2008. It was reported that the patient has pain and difficulty in rotating the arm and difficulty in movement. The nurse and the patient felt had an intrasupra splintus tear due to the injection being given in a tendon rather than the deltoid. At the time of the report, the outcome was unknown. The reporter reported that it believed to be mechanical injury on 20-OCT-2008. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration
Clinical narrative: Information has been received from a registered nurse, concerning a 20 year old female who "sometime in June " (was not sure if it given in 2008 or not) was vaccinated with her first dose of GARDASIL, intramusclar. It was reported that the patient developed a "skin discoloration" at the injection site. When the patient returned for her second dose it was given in the other arm and there was no discoloration. It was reported that the adverse event improved after stopping therapy, however at the time of the report the patient status was unspecified by the reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blister, Rash
Clinical narrative: Information has been received from the relative of a patient concerning the patient was vaccinated with 2 doses of GARDASIL.  The patient experienced rash and blisters in vaginal area after first and second doses of GARDASIL.  Unspecified medical attention was sought.  No outcomes were reported.  No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Blood test, Nausea, Pain, Ultrasound scan
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with menstrual problems who in January 2008, was vaccinated with the first dose of GARDASIL (dose and route not reported). Concomitant therapy included albuterol and Zantac. In February 2008, after getting her first dose of GARDASIL, the patient developed vomiting, nausea and stomach cramps and pain lasting about 2 days after the completion of each menstrual period. The patient took blood tests and sonograms (results not reported). She didn't get her 2nd or 3rd doses. She sought medical attention. Her vomiting, nausea, stomach cramps and pain persisted. Additional information has been requested.  12/18/08 Reviewed PCP office records. FINAL DX: epigastric pain, RAD, possible gastritis Records reveal patient experienced cold s/s, felt hot, nauseated, difficulty breathing on 3/08 visit.  RTC 7/08 w/nipple discomfort.  RTC 9/08 LLQ pain & chest pain s/p vomiting & diarrhea.  Tx w/meds. Referred to ER & cardiology.  To return if no improvement.  No further visits available.