chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Pruritus, Thermal burn
Clinical narrative: Information has been received from a registered nurse (also reported as a physician) concerning a 21 year old female who was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml. Subsequently the patient experienced excessive hair loss. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a registered nurse (also reported as a physician) concerning a 21 year old female who was vaccinated with her first dose of GARDASIL 0.5 ml.  Subsequently the patient experienced excessive hair loss.  Follow-up information has been received from a registered nurse.  Concomitant medications was not reported.  On 05-DEC-2006, the patient stated it felt like her head was burning/itching and that her hair had been steadily falling out which started 2 weeks post vaccination and was continuing to date.  The patient sought unspecified medical attention.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Burning sensation, Pruritus
Clinical narrative: Information has been received from a registered nurse (also reported as a physician) concerning a 21 year old female who was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml. Subsequently the patient experienced excessive hair loss. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a registered nurse (also reported as a physician) concerning a 21 year old female who was vaccinated with her first dose of GARDASIL 0.5 ml.  Subsequently the patient experienced excessive hair loss.  Follow-up information has been received from a registered nurse.  Concomitant medications was not reported.  On 05-DEC-2006, the patient stated it felt like her head was burning/itching and that her hair had been steadily falling out which started 2 weeks post vaccination and was continuing to date.  The patient sought unspecified medical attention.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram normal, Confusional state, Disorientation, Drug screen negative, Electroencephalogram normal
Clinical narrative: Information has been received from a physician concerning a "15 year 11 months" old female who on 17-JAN-2007 was vaccinated with her first dose of HPV vaccine (yeast).  Concomitant therapy included Citalopram hydrobromide (CELEXA). On 21-JAN-2007 the patient was disoriented and confused about her surroundings.  The patient was seen in an Emergency Department.  Blood work.  Computed axial tomography scan (CT) and drug screening were all normal.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 16 year old female (previously reported as a "15 year 11 months" old female) who on 17-JAN-2007 at 16:30 p.m. was vaccinated with her second dose of GARDASIL (Lot number 653978/0955F) intramuscuarly in left deltoid. It was reported that there was no illness at the time of vaccination. Concomitant therpay included CELEXA. On 21-JAN-2007 around 17:30 p.m. the patient was disoriented and confused about her surroundings. The patient "did not know who anyone was". The patient was seen in an Emergency Department. Head computed axial tomography scan (CT), drug screen, BHCG, CBC, complete metabolic profile, PT, thyroid tests and EEG were all normal. There was "some concern of a psychiatric etiology". The patient was "still not back to normal until 23-JAN-2007". Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling abnormal, Full blood count normal, Laboratory test, Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning a "15 year 11 months" old female who on 17-JAN-2007 was vaccinated with her first dose of HPV vaccine (yeast).  Concomitant therapy included Citalopram hydrobromide (CELEXA). On 21-JAN-2007 the patient was disoriented and confused about her surroundings.  The patient was seen in an Emergency Department.  Blood work.  Computed axial tomography scan (CT) and drug screening were all normal.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 16 year old female (previously reported as a "15 year 11 months" old female) who on 17-JAN-2007 at 16:30 p.m. was vaccinated with her second dose of GARDASIL (Lot number 653978/0955F) intramuscuarly in left deltoid. It was reported that there was no illness at the time of vaccination. Concomitant therpay included CELEXA. On 21-JAN-2007 around 17:30 p.m. the patient was disoriented and confused about her surroundings. The patient "did not know who anyone was". The patient was seen in an Emergency Department. Head computed axial tomography scan (CT), drug screen, BHCG, CBC, complete metabolic profile, PT, thyroid tests and EEG were all normal. There was "some concern of a psychiatric etiology". The patient was "still not back to normal until 23-JAN-2007". Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood human chorionic gonadotropin normal, Computerised tomogram normal, Confusional state, Differential white blood cell count normal, Disorientation
Clinical narrative: Information has been received from a physician concerning a "15 year 11 months" old female who on 17-JAN-2007 was vaccinated with her first dose of HPV vaccine (yeast).  Concomitant therapy included Citalopram hydrobromide (CELEXA). On 21-JAN-2007 the patient was disoriented and confused about her surroundings.  The patient was seen in an Emergency Department.  Blood work.  Computed axial tomography scan (CT) and drug screening were all normal.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 16 year old female (previously reported as a "15 year 11 months" old female) who on 17-JAN-2007 at 16:30 p.m. was vaccinated with her second dose of GARDASIL (Lot number 653978/0955F) intramuscuarly in left deltoid. It was reported that there was no illness at the time of vaccination. Concomitant therpay included CELEXA. On 21-JAN-2007 around 17:30 p.m. the patient was disoriented and confused about her surroundings. The patient "did not know who anyone was". The patient was seen in an Emergency Department. Head computed axial tomography scan (CT), drug screen, BHCG, CBC, complete metabolic profile, PT, thyroid tests and EEG were all normal. There was "some concern of a psychiatric etiology". The patient was "still not back to normal until 23-JAN-2007". Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug screen, Electroencephalogram normal, Full blood count normal, Laboratory test normal, Metabolic function test normal
Clinical narrative: Information has been received from a physician concerning a "15 year 11 months" old female who on 17-JAN-2007 was vaccinated with her first dose of HPV vaccine (yeast).  Concomitant therapy included Citalopram hydrobromide (CELEXA). On 21-JAN-2007 the patient was disoriented and confused about her surroundings.  The patient was seen in an Emergency Department.  Blood work.  Computed axial tomography scan (CT) and drug screening were all normal.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 16 year old female (previously reported as a "15 year 11 months" old female) who on 17-JAN-2007 at 16:30 p.m. was vaccinated with her second dose of GARDASIL (Lot number 653978/0955F) intramuscuarly in left deltoid. It was reported that there was no illness at the time of vaccination. Concomitant therpay included CELEXA. On 21-JAN-2007 around 17:30 p.m. the patient was disoriented and confused about her surroundings. The patient "did not know who anyone was". The patient was seen in an Emergency Department. Head computed axial tomography scan (CT), drug screen, BHCG, CBC, complete metabolic profile, PT, thyroid tests and EEG were all normal. There was "some concern of a psychiatric etiology". The patient was "still not back to normal until 23-JAN-2007". Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Prothrombin time normal, Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning a "15 year 11 months" old female who on 17-JAN-2007 was vaccinated with her first dose of HPV vaccine (yeast).  Concomitant therapy included Citalopram hydrobromide (CELEXA). On 21-JAN-2007 the patient was disoriented and confused about her surroundings.  The patient was seen in an Emergency Department.  Blood work.  Computed axial tomography scan (CT) and drug screening were all normal.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 16 year old female (previously reported as a "15 year 11 months" old female) who on 17-JAN-2007 at 16:30 p.m. was vaccinated with her second dose of GARDASIL (Lot number 653978/0955F) intramuscuarly in left deltoid. It was reported that there was no illness at the time of vaccination. Concomitant therpay included CELEXA. On 21-JAN-2007 around 17:30 p.m. the patient was disoriented and confused about her surroundings. The patient "did not know who anyone was". The patient was seen in an Emergency Department. Head computed axial tomography scan (CT), drug screen, BHCG, CBC, complete metabolic profile, PT, thyroid tests and EEG were all normal. There was "some concern of a psychiatric etiology". The patient was "still not back to normal until 23-JAN-2007". Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: On 1/25/07 pt received #2 HepA-HepB vaccination in right arm after incident and wanted 15 min after injection at clinic.  On 2/8/07 pt reported that he had a high fever, sweats, chills and HA for 2 days following that vaccination, stayed in bed and recovered.  he did not report ADR prior to 2/9/07 because of language barrier.  Client did not seek medical attention for reaction and on mutual agreement-will not be administered th 3rf HepA-Hep series.
Age: 1.01
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Varicella
Clinical narrative: Pt developed varicella 2/11/07 despite receiving Varivax 7/20/06, no NO way known contacted varicella or Zoster.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: MMRV given in rt lat thigh sub Q on 2-5-07 Mon at 2:30pm, site reaction was noticed about 24 hours later. Small bumps under the skin 6x6 inch area red, hot, swollen and painful developed and lasted 48 hours before it began to resolve.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Local RX to vaccine MMR-V 2/13/07 1" x 1" swollen red, hot to touch area on R arm.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Blister, Culture negative, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: MMRV given in Rt upper arm SQ. Site reaction developed 24 hours later. 3x3 area was red, hot, swollen and painful. 48 Hrs after large water blisters developed.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: MMRV given in Rt upper arm SQ. Site reaction developed 24 hours later. 3x3 area was red, hot, swollen and painful. 48 Hrs after large water blisters developed.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: MMRV (ProQuad) given > age 12 years.
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None, MMRV ProQuad given >12 years old.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Contusion, Petechiae, Platelet count decreased
Clinical narrative: Petechiae noted on trunk and extremities onset 1/12 per patient 5 am bruise noted on forearm states also has one on thigh but refused to display, afebrile denies blood in stool or urine referred to local ER then transferred to hospital.  02/22/2007 MR received from public health dept for  teenager who moved from another country in September 2006.  He developed petechiae on 01/12/2007 and some bruising on the arm and thigh.  Admitted to hospital on 01/17/2007.  Txd with IVGG with resulting increase in platelet count.  INH stopped.  D/C on 01/19/2007 INH started again 01/26/2007 Multiple vaccines received 01/05/2007.  03/05/2007 Hospital MR received for a 2 night ER admission for a finding of thrombocytopenia at another facility, accompanied by bruising, gingival bleeding, and epistaxis.  Platelet transfusion given as well as IVIG.   PE reveals (+) gingival bleeding.  Scattered petechiae on face, chest, and abdomen.  Scattered bruising bilaterally on lower extremities. Discharged with outpatient F/U.  Discharge DX: Idiopathic Thrombocytopenia Purpura.  Latent Tuberculosis.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, MMRV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: 2/14/07 Mother called in child has a reddened ring around the injection site approximately 1 inch in diameter. Child complain of itching of entire arm. Mother called doctor's office per RN request. Office recommended use of cortisone cream.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Swelling face, Urticaria
Clinical narrative: Facial swelling, hives, low grade fever
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea, dizziness
Age: 1.05
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Tremor
Clinical narrative: Parents report temp "110 degrees" had generalized "shaking" was given one shot, Tylenol, and prescription for 1 dose qd for 5 days. Seen at facility.  4/13/07 Received medical records from hospital which reveal patient seen in ER on 12/10/06 for possible febrile seizure, nasal congestion & ear pain w/vomiting x 1.  Temp 102.6.  TM's distended, right greater than left.  Anterior lymphadenopathy present bilaterally.  Given antibiotics in ER & upon d/c. FINAL DX: Febrile seizure, right otitis media.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Body temperature, Pruritus, Skin lesion
Clinical narrative: 2-9-07 Varicella vaccine given. 2-11-07 Temperature 100. 2-14-07 Clear fluid filled blisters on abdomen, back and hands. 2-15-07 Pruritic lesions > 300 (according to mother) from head to feet.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Blood culture, Convulsion, Full blood count, Pyrexia, Urticaria
Clinical narrative: Received vaccines 2/12/07 at 0930 broke out in hives 2/13/07 and received Benadryl hives resolved. Developed fever 103-104 2/14/07 and had seizure at 1030 2/14/07 taken to ER.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt has redness, swelling (large amt), tenderness, and warm to touch at injection site
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy, Ultrasound scan, Wrong drug administered
Clinical narrative: Initial and follow up information has been received through the Merck regulatory pregnancy registry from a registered nurse at a health department and an unspecified family member concerning a 23 year old white female smoker who was 34 weeks pregnant with cervical incompetence, allergies to erythromycin and moxifloxacin hydrochloride (AVALOX) and had a history of premature labour from a prior pregnancy, a history of 3 pregnancies and 2 live births, a yeast infection, a threatened abortion, "ruptured membranes/delivery" and cervical dysplasia that had required a LEEP surgery, however, this procedure was not performed as the patient became pregnant.  On 14-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), gestational sac only, negative fetal heart tone, right corpus". On 21-APR-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus". On 02-MAY-2006, the patient underwent an ultrasound which revealed "positive intrauterine pregnancy (IUP), positive fetal heart tone, singleton, right corpus" and "gestational age, threatened abortion". On 26-JUN-2006, the patient underwent a maternal serum alphafetoprotein (MSAFP) which revealed "in range normal". It was reported that on an unspecified date, the patient had been hospitalized due to "lower back contractions". The patient had been diagnosed with a kidney infection and was advised to see her primary care physician for a flu shot. On 17-OCT-2006, (conflicting information also reported as 20-OCT-2006), the patient went to her physician and received one dose of 0.5 mL of HPV rL1 6 11 16 18 VLP vaccine (yeast) administered intramuscularly instead of the flu shot. Concomitant therapy included prenatal vitamins and unspecified therapies (reported as "tributylene", "suflexan" and "cyclomenzaprene"). On 16-OCT-2006 (conflicting information also reported as 20-OCT-2006), the patient was not having any adverse reaction. It was reported that the patient had already been experiencing pre-term labour, prior to receiving the shot.  The patient sought unspecified medical attention. On 24-OCT-2006, the patient received a 1 cc flu shot. On 02-NOV-2006, the patient received betamethasone (CELESTONE), 12 mg, intramuscularly to "decrease contractions". On 06-NOV-2006, the patient underwent an ultrasound which revealed "amniotic fluid index=28.4" and "rule out ruptured membranes". On 15-NOV-2006, 16-NOV-2006, and 20-NOV-2006, the patient underwent a fetal nonstress test (NST) (results not reported). On an unspecified date, the patient received acetaminophen/codeine phosphate (TYLENOL WITH CODEINE #3) for migraines.  At the time of this report, the outcome of the events were unknown.  The reporter stated that the patient had been hospitalized  "prior to receiving the hpv rl1 6 11 16 18 vlp vaccine (yeast) vaccination for an unrelated kidney infection and lower back contractions". Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning an approximately 17 year old female with plantar warts since August 2005 who in August 2006, was vaccinated with fist dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication.  In September 2006, the patient received second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 1 month after the first dose.  The patient sought medical attention. The physician noted as of 16-NOV-2006, the patient's plantar warts resolved.  The patient noticed that the plantar warts resolved (on an unspecified date in 2006) after the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) was received.  A different physician administered the HPV rL1 6 11 16 18 VLP vaccine (yeast).  No other information was available at the time of reporting.  Additional information was received from the physician who reported that is not an adverse event.  The warts had been present for 2 years and were refractory to liquid nitrogen, imiquimod (ALDARA CREAM), and laser treatment.  Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: FLU3, HIBV, HPV4, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Pyrexia, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a physician and an office manager concerning a 12 month old white female patient with no past medical history who on 15-DEC-2006 was vaccinated with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant vaccinations on the same day included a first dose of measles-mumps-rubella vaccine (MSD) SC into the left leg, Hib conj vaccine (OMPC) (manufacturer unknown) and a first dose of varicella virus vaccine live (MSD) SC into the left leg. Other concomitant vaccinations included a first dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (lot# 427U7AA) IM into the right leg. It was reported that the patient received HPV rL1 6 11 16 18 VLP vaccine (yeast) by accident.  She was supposed to receive a dose of pneumococcal 4 6B 9V 14 18C 23F conj vaccine (CRM197) (PREVNAR). The reporter stated that the products were clearly labeled; there was not a confusion of products.  It was "lack of education" of the medical assistant working on the office.  The parents reported the patient had slight fever on 16-DEC-2006 (also reported as the 17-DEC-2006).  Subsequently, the patient was seen in the office on 18-DEC-2006 and had recovered from slight fever. There were no there reported problems or "any other adverse events." Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a nurse concerning her daughter, a 13 year old female who on 27-DEC-2006 was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 27-DEC-2006 the patient developed dizziness and nausea. The patient's dizziness and nausea persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Fall, Feeling abnormal, Headache, Injury, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no illness at the time of vaccination who on 08-DEC-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot 653938/0954F). On 08-DEC-2006, the patient was concomitantly vaccinated with a first dose of Menatra, a dose of influenza virus vaccine (unspecified) and a dose of Boostrix. On 08-Dec-2006, the patient fainted shortly after vaccination. She fell from a standing position and hit the back of head on the floor. She was unconscious for approximately 30 seconds,a and then was dazed and pale. The patient was "ok" after a few minutes. The patient complained of a headache, frontal to occipital. The patient was "ok" at home later that evening. The patient recovered with no sequalae on 08-DEC-2006. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no illness at the time of vaccination who on 08-DEC-2006 was vaccinated with a 0.5 ml first dose of Gardasil (yeast) (lot 653938/0954F). On 08-DEC-2006, the patient was concomitantly vaccinated with a first dose of Menatra, a dose of influenza virus vaccine (unspecified) and a dose of Boostrix. On 08-Dec-2006, the patient fainted shortly after vaccination. She fell from a standing position and hit the back of head on the floor. She was unconscious for approximately 30 seconds,a and then was dazed and pale. The patient was "ok" after a few minutes. The patient complained of a headache, frontal to occipital. The patient was "ok" at home later that evening. The patient recovered with no sequalae on 08-DEC-2006. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a female patient who in November 2006, was vaccinated with the second dose of Gardasil (yeast). It was reported that the patient received the first vaccination in September 2006. On 21-Dec-2006, the patient underwent an "HPV DNA" test. The results indicated that the patient tested positive for HPV type 16. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Cough, Pyrexia, Sinus congestion
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient with NKDA who on 01-DEC-2006 was vaccinated into the left deltoid with a first dose of Gardasil (yeast) (lot#653978/0955F). At the time of vaccination the patient had "mild URI symptoms and a cold" with no fevers. In the week following vaccination, the patient developed a temperature of 101.5 and her URI progressed to sinus congestion and cough. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hypertension
Clinical narrative: Information has been received from a physician concerning a 14 year old female who in approximately December 2006, " a few weeks ago," was vaccinated with a dose of Gardasil (yeast) (lot#654885/1424F). Subsequently, "after her first shot" the patient developed hypertension. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 03-Jan-2007 was vaccinated with a 0.5 ml dose of Gardasil (yeast). There was no concomitant medication. On 03-Jan-2007, after receiving the vaccination, the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Menstruation irregular
Clinical narrative: Information has been received from a nurse practitioner and certified medical assistant concerning a  13 year old female who on 24-OCT-2006 was vaccinated intramuscularly into the left deltoid with a first 0.5 mL dose of Gardasil (yeast) (lot# 653937/0637F). There was no concomitant medication. She was administered a second 0.5 ml dose of Gardasil (yeast), intramuscularly (Lot # 653735/0688F) into the right detoid on 26-DEC-2006. There was no illness at the time of vaccination.  It was reported that the patient, who has had her regular menses since the age of 10, had not had her regular menses in November 2006 or December 2006. The medical assistant further reported that the patient's menses stopped in October 2006 after the first dose and she had no menses in November or December 2009. she started her meneses in January 2007 and in Febraury 2007, saw a physician for tests (unspecified). All was reported to be ok. The patient reported no other problems and was not reported to be pregnant. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. All was reported to be ok. The patient reported no other problems and was not reported to be pregnant. Addtional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a registered pharmacist, also the patient, via a company representative, concerning herself. The pharmacist reported that during her second dose of Gardasil (yeast), she experienced a tremendous amount of stinging. She also noted that the second day after vaccination she was still very sore. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning four patients who were vaccinated with Gardasil (yeast). Subsequently the four patients experienced a fainting episode. At the time of the report, it was not reported if the four patients recovered. 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. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Body temperature normal, Contusion, Hyperaemia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL. On 07-Dec-2006 the patient experienced significant arm pain, including through the passive motion. The physician reported that the patient was sent to see an orthopedic physician on 03-JAN-2007 because the patient was a dancer and could not dance with extreme pain. At the time of this report, the outcome was unknown. It was also reported that the patient was vaccinated with a first dose of GARDASIL on 12-OCT-2006 and there was no adverse experience with this initial dose. No product quality complaint involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up informtion has been received froma physician and medical records concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL vaccine (Lot  number 653938/0954F). On 07-DEC-2006 the patient experienced significant arm pain, including through passive motion, limitating activities. The patient was again seen in the physicia's office on 14-DEC-2006 still with "arm hurting". During physical examination, it was noted that the patient had a "small 1 cm greenish older bruise with no palpable mass in the deltoid area". The patient was treated with ALEVE, 2 tablets orally twice a day as necessary for pain. The patient returned to the physician's office on 20-DEC-2006 still with "arm sore, still unable to move to do some dance" (previously reported as could not dance with extreme pain). Physical examination noted the deltoid area with no palpable mass, tenderness to palpation by report but with no wincing or guarding, and slight hyperemia". The physician referred the patient to an orthopedic physician. The patient was seen in the orthopedic physician's office on 04-Jan-2007. According to the orthopedic physician's office notes, the patient's pain was localized to the injection site over the mid aspect of the deltoid muscles. This pain was associated with any overhead lifting and some weakness. There was no pain with rest. An x-ray of the shoulder are showed no evidence of bony abnormalities or myositis ossificans. The orthopedic physician's assessment was that the patient had "a little residual irritation from the injection site, and the pain may be associated with some residual muscle spasms". The patient was prescribed FLEXERIL. It was also reported that the patient was vaccinated with a first dose of  GARDASIL vaccine on 12-OCT-2006 and there was no adverse experience with this initial dose. Follow-up received on 7-FEB-2007 contained the following adverse experiences: rotational scoliosis (4-JAN-2007), and pharyngitis (20-DEC-2006). Additional informatinis not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain, Pain in extremity, Tenderness, X-ray limb normal
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL. On 07-Dec-2006 the patient experienced significant arm pain, including through the passive motion. The physician reported that the patient was sent to see an orthopedic physician on 03-JAN-2007 because the patient was a dancer and could not dance with extreme pain. At the time of this report, the outcome was unknown. It was also reported that the patient was vaccinated with a first dose of GARDASIL on 12-OCT-2006 and there was no adverse experience with this initial dose. No product quality complaint involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up informtion has been received froma physician and medical records concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL vaccine (Lot  number 653938/0954F). On 07-DEC-2006 the patient experienced significant arm pain, including through passive motion, limitating activities. The patient was again seen in the physicia's office on 14-DEC-2006 still with "arm hurting". During physical examination, it was noted that the patient had a "small 1 cm greenish older bruise with no palpable mass in the deltoid area". The patient was treated with ALEVE, 2 tablets orally twice a day as necessary for pain. The patient returned to the physician's office on 20-DEC-2006 still with "arm sore, still unable to move to do some dance" (previously reported as could not dance with extreme pain). Physical examination noted the deltoid area with no palpable mass, tenderness to palpation by report but with no wincing or guarding, and slight hyperemia". The physician referred the patient to an orthopedic physician. The patient was seen in the orthopedic physician's office on 04-Jan-2007. According to the orthopedic physician's office notes, the patient's pain was localized to the injection site over the mid aspect of the deltoid muscles. This pain was associated with any overhead lifting and some weakness. There was no pain with rest. An x-ray of the shoulder are showed no evidence of bony abnormalities or myositis ossificans. The orthopedic physician's assessment was that the patient had "a little residual irritation from the injection site, and the pain may be associated with some residual muscle spasms". The patient was prescribed FLEXERIL. It was also reported that the patient was vaccinated with a first dose of  GARDASIL vaccine on 12-OCT-2006 and there was no adverse experience with this initial dose. Follow-up received on 7-FEB-2007 contained the following adverse experiences: rotational scoliosis (4-JAN-2007), and pharyngitis (20-DEC-2006). Additional informatinis not expected.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of Gardasil (yeast) (lot number not reported). The nurse reported that the patient, after receiving the Gardasil (yeast), did not receive her next expected period. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from al licensed practical nurse concerning a 17 year old female with no pertinent medical history, who on 02-JAN-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. The nurse reported that the patient received the vaccination via the subcutaneous route and on 02-JAN-2007, developed in injection site reaction. The reaction was described as being that of a swollen and bruised injections site on the patients shoulder. Unspecified medical attention was sought. The patient subsequently recovered on 03-JAN-2007.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Fall, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil. subsequently, following vaccination, the patient loss consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a physician and a medical assistant concerning a 15 year old female with no past medical history, who on 29-DEC-2006, at 11:15 AM was vaccinated in the right arm with the first dose of GARDASIL (0.5 ml).  There were no illnesses at time of vaccination.  Subsequently, following vaccination, on 29-DEC-2006 at 11:20 AM the patient felt week and dizzy, then stated that she felt sick to her stomach.  The patient suddenly fell forward into her mother's arms, and passed out.  The patient was passed out for less then a minute.  The patient was given something to eat and drink and was kept in the office for 30 minutes.  After the 30 minutes, the patient stated that she was fine.  No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of Gardasil. subsequently, following vaccination, the patient loss consciousness. The patient regained consciousness after a few minutes. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a physician and a medical assistant concerning a 15 year old female with no past medical history, who on 29-DEC-2006, at 11:15 AM was vaccinated in the right arm with the first dose of GARDASIL (0.5 ml).  There were no illnesses at time of vaccination.  Subsequently, following vaccination, on 29-DEC-2006 at 11:20 AM the patient felt week and dizzy, then stated that she felt sick to her stomach.  The patient suddenly fell forward into her mother's arms, and passed out.  The patient was passed out for less then a minute.  The patient was given something to eat and drink and was kept in the office for 30 minutes.  After the 30 minutes, the patient stated that she was fine.  No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL. Subsequently, following the second vaccination, the patient experienced irregular periods. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who on an unspecified date was vaccinated with the first dose of Gardasil, injection, 0.5ml. Concomitant medications was not reported. Subsequently on an unspecified date, the patient developed a rash on her chest and arm after receiving the first dose of Gardasil. The physician gave the patient an antihistamine (unspecified) and the rash on her chest and arm cleared in about 20 minutes. Subsequently the same day, the patient recovered from rash on her chest and arm. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 23 year old, female student with no pertinent medical history who on an unspecified date was vaccinated, intramuscularly, into the deltoid with the first dose of GARDASIL injection 0.5 ml. Concomitant medication was not reported. Subsequently on an unspecified date, the patient developed a rash on her chest and arm after receiving the first dose of GARDASIL. The physician gave the patient an antihistamine (unspecified) and the rash on her chest and arm cleared in about 20 minutes. Subsequently the same day, the patient recovered from the rash on her chest and arms. Additional information is not available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with pertinent medical history reported as none and allergic reaction to some antibiotics who on 06-SEP-2006 was vaccinated with the first dose of Gardasil. Concomitant medication was reported as none. On approximately 06-SEP-2006, the patient developed injection site pain that lasted 3 days following vaccination with Gardasil. On an unspecified date, the patient sought unspecified medical attention. On approximately 08-SEP-2006, the patient recovered from injection site pain. The patient had not received her second dose of Gardasil. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test negative, Uterine haemorrhage
Clinical narrative: Information has been received from a registered nurse and physician assistant certified concerning a 16 year old female with on known drug allergies, no illness at time of being vaccinated, and no medical history who on 30-DEC-2006 was vaccinated with first dose of Gardasil (lot #654741/1208F) intramuscularly left deltoid at 1400 hours. There was no concomitant medication. On 01-JAN-2007, at 1400 hours the patient experienced abnormal uterine bleeding (Spotting) uncomplicated and sought medical attention. The patient already had her period (normal menses 27-DEC-2006) and had been "spotting all during this past week". They thought pregnancy was possible so they administered a urine pregnancy test (negative) and she was not pregnant. She had no abdominal pain and no previous history of abnormal uterine bleeding. The outcome of the uterine bleeding was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her niece a female (age not reported) with pertinent medical history and drug reactions/allergies not reported who in 2006 was vaccinated with the first and second doses of Gardasil, IM (1st and 2nd dose over a two month period). Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced vomiting and diarrhea after the first and second doses of Gardasil series. The patient sought unspecified medical attention. The nurse reported that the patient does not plan to have the third dose as recommended. Subsequently on an unspecified date, the patient recovered from vomiting and diarrhea. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site rash, Tenderness
Clinical narrative: Information has been received from a physician and the mother of a 12 year old female with pertinent medical history and drug reactions/allergies reported as none who on 19-DEC-2006 was vaccinated with the first dose of Gardasil (lot #655165/1425F). concomitant therapy included tetanus toxoid. On 28-DEC-2006, the patient experienced a rash at the injection site right after receiving the vaccination. The patient also experienced mild headaches almost immediately. A few days later the patient's headaches became more intense. The patient still experienced intermittent headaches but the severity has not decreased. On 31-DEC-2006, the patient presented to the physician office and complained that she had a headache for four days. The patient was told by the physician to increase the dosage of Motrin. On 01-JAN-2007, the patient presented to the physician office again and stated that she was not better and still had a headache. The physician stated when the patient pressed over her sinus area it seemed tender. The patient was treated with oral antibiotics. The patients headache persisted. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a pharmacy intern concerning an 18 year old female with no pertinent medical history and no known adverse drug reactions and no known allergies reported. On 04-JAN-2007, the patient was vaccinated intramuscularly in the left arm with the first 0.5ml dose of Gardasil (lot #653736/0689F). There were no concomitant medications reported. On 05-JAN-2007, in the morning, the patient developed tingling in the fingers of her left hand with pain in the fingertips when touching anything. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow up information has been received from a pharmacy intern concerning an 18 year old female student with no pertinent medical history and no known adverse drug reactions and no known allergies reported. On 04-JAN-2007, at 4:55 PM, the patient was vaccinated intramuscularly in the left deltoid with the first 0.5 mL dose of GARDASIL (Lot # 653736/0689F). There were no concomitant medications reported. There were no known illnesses at the time of vaccination. On 05-Jan-2007, at 9:30 AM, upon waking in the morning, the patient developed a tingling, burning sensation on fingers (previously reported as tingling in the fingers of her left hand with pain in fingertips when touching anything). It was reported that the events spontaneously resolved by the following morning. On 06-JAN-2007, the patient had recovered from the events. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with a sulfonamide allergy and no other pertinent medical history reported. On 22-DEC-2006, the patient was vaccinated with 0.5ml of Gardasil ( Lot #655165/1425F). There were no concomitant medications reported. On 29-DEC-2006, one week after the injection, the patient developed a rash on her arms, legs and abdomen. The patient sought unspecified medical attention. It was reported that the rash had since cleared up but the date was unknown. At the time of this report, the patient had recovered from the event. Additional information has been requested. 5/14/10 Follow up: The patient took Benadryl for 24 hours and itching resolved. No diagnostic laboratory tests were performed. On 12-JAN-2007, the patient had recovered completely. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Information has been received from a physician concerning a 25 year old female with no drug allergies who on 27-Dec-2006 was vaccinated with the first dose of Gardasil (yeast). Concomitant therapy included ZITHROMAX. Subsequently, on an unspecified date, the patient experienced nausea and dizziness. The patient did not seek medical attention. No diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested. 5/14/10 Follow up: Subsequently, on 02-JAN-2007, the patient experienced headache, nausea and dizziness. The patient repsonded to Phenergan and Transderm scop. No diagnostic studies were performed. On 04-JAN-2007, the patient recovered from headache, nausea and dizziness. No product quality complaint was involved. No additional information is expected.