chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Condition aggravated, Migraine, Pyrexia
Clinical narrative: Information has been received from a healthcare professional concerning a 25 year old female patient with migraines and an allergic reaction to CECLOR and SEPTRA who on 22-AUG-2007, was vaccinated IM with a first dose of Gardasil (Lot# 658556/1060U).  There was no concomitant medication.  On 26-AUG-2007, the patient experienced fever and chills.  It was reported that these symptoms lasted for several days.  On 28-AUG-2007, the patient experienced migraines.  Unspecified medical attention was sought.  On 29-AUG-2007, the patient called the office.  No laboratory diagnostic studies were performed.  After several days, the patient recovered from fever and chills but had not recovered from migraines.  It was also reported that the patient had not had a "migraine attack" for years.  No product quality complaint was involved.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. On 26-AUG-2007, the patient experienced fever, chills and migraines. It was reported that these symptoms lasted for several days. Unspecified medical attention was sought. On 29-AUG-2007, the patient called the office. No laboratory diagnostic studies were performed. After several days, the patient recovered from fever and chills but had not recovered from migraines. It was also reported that the patient had not had a "migraine attack" for years. No product quality complaint was involved. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain, Skin lesion
Clinical narrative: Information has been received from a physician concerning a female who on 24-JUL-2007 was vaccinated with the third dose of Gardasil.  On 24-JUL-2007, the patient experienced injection site pain.  The patient was scheduled for an appointment to be seen in the office on 30-AUG-2007.  At the time of this report, the patient was not recovered.  Additional information has been requested. Initial and follow-up information has been received from a health professional concerning a 26 year old white female who on 24-JUL-2007 was vaccinated IM in the left deltoid with the third dose of GARDASIL (lot #0469U). On 24-JUL-2007, the patient experienced persistent pain at the left deltoid injection site without a visible lesion. It was also reported that the patient's shoulder was increasingly painful with movement at the injection site. The patient was scheduled for an appointment to be seen in the office on 30-AUG-2007. At the time of this report, the patient's pain was resolving and was described as "once a week and brief." Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 09-AUG-2007 was vaccinated IM with a 0.5 mL dose of Gardasil (lot #658490/0802U).  There was no concomitant medication.  On 09-AUG-2007, the patient experienced pain and soreness in her arm (unspecified).  On an unspecified date in August 2007, the patient was seen by the physician, who reported that when the patient raised her arm and activated the deltoid muscle, there was pain.  Upon examination, there was no swelling and no nodule noted.  At the time of this report, the patient was not recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a 16 year old female, who on 16-APR-2007 was vaccinated with a first dose of Gardasil (Lot# 656050/0245U).  Subsequently, after receiving the vaccination the patient experienced a heavy menstrual cycle.  No laboratory diagnostics were performed.  The patient sought unspecified medical attention.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female with a history of syncope (during a blood draw) who was vaccinated with a dose of Gardasil.  Concomitant therapy, on the same day, included a dose of MENACTRA.  Subsequently the patient experienced syncope.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from syncope.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a healthcare professional concerning a 17 year old female who on 29-AUG-2007 was vaccinated with a first 0.5 ml dose of Gardasil.  Concomitant therapy included a dose of MENACTRA.  Within 15 minutes, the patient passed out twice.  Unspecified medical attention was sought.  On 29-AUG-2007, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 22-AUG-2007 was vaccinated with a first dose Gardasil.  There was no concomitant medication.  On 23-AUG-2007 the patient experienced hives.  Unspecified medical attention was sought.  Subsequently, the patient recovered from hives.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Information has been received from a physician concerning a 15 year old female who on 22-AUG-2007 was vaccinated IM in the right deltoid with a 0.5 ml of a first dose of GARDASIL (Lot # 0210U). On 16-AUG-2007 the patient had been vaccination with the first dose of MENACTRA. On 23-AUG-2007 the patient experienced hives one day post vaccination of the first dose GARDASIL. She was treated with BENADRYL. Unspecified medical attention was sought. Subsequently, on an unspecified date the patient recovered from the event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer, concerning her 17 year old daughter, who on an unknown date was vaccinated with the third dose of Gardasil.  There was no concomitant medication.  On 29-AUG-2007 the patient had a Pap smear that was positive for human papilloma virus.  At the time of this report, the patient had not recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Injection site pain, Pregnancy test positive, Smear cervix, Tenderness
Clinical narrative: Information has been received for the Pregnancy Registry for Gardasil from a 21 year old female licensed visiting nurse with no pertinent medical history or drug reactions/allergies who on 17-AUG-2007 was vaccinated with a first dose of Gardasil (lot# unknown).  No concomitant medication was used.  On 17-AUG-2007 the patient discovered she was pregnant.  The patient's date of last menstrual period was 27-JUL-2007.  Medical attention was sought.  On 17-Aug-2007 a Papanicolaou test  was performed and the results were unspecified.  A beta-human chorionic gonadotropin test (unspecified) was performed and was positive.  The patient also reported soreness at the injection site.  As of 29-AUG-2007 the arm is still tender.  The estimated date of delivery was 02-MAY-2007.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient developed soreness in her arm.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Stomach discomfort
Clinical narrative: Information has been received from a pharmacist concerning an approximately 20 year old female with no pertinent medical history who on 28-AUG-2007 was vaccinated with a first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified).  On 29-AUG-2007 the patient experienced stomach upset.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Erythema, Oedema peripheral, Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old white female with no pertinent medical history who on 26-JUN-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot #0469U).  Concomitant therapy included an unspecified anti-histamine and ADVIL.  Subsequently, the patient experienced redness and swelling on right hand and a sharp shooting pain in left lower quadrant of pelvic area.  Subsequently, the patient recovered.  On 28-AUG-2007, the patient was vaccinated into the right deltoid with a second dose of Gardasil (lot #0469U).  On 28-AUG-2007 the patient experienced shooting pain in left lower quadrant of pelvic area, swelling and redness on right hand.  The patient called the physician's office on 28-AUG-2007.  On 28-AUG-2007 the patient recovered from redness and swelling of the right hand after about one hour, on approximately 31-AUG-2007 after 1-4 days she recovered from the sharp shooting pain in the left lower pelvic region. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood insulin, Drug exposure during pregnancy, Full blood count, Laboratory test, Lipids
Clinical narrative: Information has been received from the Pregnancy Registry for GARDASIL from a License Practical Nurse (L.P.N.) concerning a 14 year old female patient who on 29-MAY-2007 was vaccinated IM with a dose of GaARDASIL lot #654535/0960F and found to be pregnant on 06-JUN-2007.  The patient came into the office for a physical because of complaints of an irregular period and was given the injection as a routine immunization.  The laboratory test complete metabolic profile (CMP), human chorionic gonadotropin test (HCG), insulin levels, lipid profile, thyroid panel and complete blood count with differential (CBC with diff) were done.  Results are not available.  The outcome was unknown.  Additional information has been requested. oN 06-JUN-2008, follow up information received from the licensed practical nurse reported that the patient had a full term healthy and normal female by vaginal delivery on 17-OCT-2007. No further information is availble.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Pregnancy test, Thyroid function test
Clinical narrative: Information has been received from the Pregnancy Registry for GARDASIL from a License Practical Nurse (L.P.N.) concerning a 14 year old female patient who on 29-MAY-2007 was vaccinated IM with a dose of GaARDASIL lot #654535/0960F and found to be pregnant on 06-JUN-2007.  The patient came into the office for a physical because of complaints of an irregular period and was given the injection as a routine immunization.  The laboratory test complete metabolic profile (CMP), human chorionic gonadotropin test (HCG), insulin levels, lipid profile, thyroid panel and complete blood count with differential (CBC with diff) were done.  Results are not available.  The outcome was unknown.  Additional information has been requested. oN 06-JUN-2008, follow up information received from the licensed practical nurse reported that the patient had a full term healthy and normal female by vaginal delivery on 17-OCT-2007. No further information is availble.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 28-AUG-2007 was vaccinated with Gardasil.  On 28-AUG-2007, the patient passed out after receiving the vaccination.  Unspecified medical attention was sought.  On 28-AUG-2007, the patient recovered.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Migraine with aura
Clinical narrative: Information has been received from an 18 year old female healthcare worker with a history of becoming "non-responsive" after getting a pertussis vaccine who in January 2007, was vaccinate IM with her first dose of Gardasil.  There was no AE after the first dose.  In March 2007, the patient received her second IM dose of Gardasil.  An hour after the second dose, she developed an ocular migraine and then later a "regular migraine".  Medical attention was sought.  The patient recovered in March, 2007.  A month later (in April, 2007) she had a "smaller one".  The outcome of the April 2007 migraine was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a dose of Gardasil.  Subsequently the patient became woozy "almost immediately after vaccination".  Medical attention was not sought.  The patient recovered before leaving the office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a  physician concerning a female who was vaccinated intramuscularly with a dose of Gardasil.  Subsequently the patient became woozy "almost immediately after vaccination".  Medical attention was not sought.  The patient recovered before leaving the office.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 15 year old female patient, with no pertinent medical history, who on 16-AUG-2007 was vaccinated in the deltoid, with the first dose of Gardasil (Lot #658558/1061U).  There was no concomitant medication.  On 17-AUG-2007, the patient developed nausea, vomiting and diarrhea.  On 24-AUG-2007, she visited her primary care physician, and he advised her to keep herself well hydrated.  No medical treatment was prescribed.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchitis, Cough, Dyspnoea
Clinical narrative: Information has been received from a grandmother concerning her 14 year old granddaughter with penicillin allergy who on 14-AUG-2007 was vaccinated with a dose of Gardasil.  There was no concomitant medication.  On approximately 21-AUG-2007 the patient developed bronchitis.  Unspecified medical attention was sought.  The patient's bronchitis persisted with coughing and breathing problems.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning her daughter with no pertinent medical history, who on 23-AUG-2007 was vaccinated with a first dose of Gardasil.  There was no concomitant medication.  On 24-AUG-2007 the patient experienced urticaria than began bilaterally on the legs.  On 25-AUG-2007 the rash progressed to her trunk, upper extremities, neck and face.  The physician was notified by telephone and the patient did not need BENADRYL.  On 27-AUG-2007, the patient recovered.  No laboratory or diagnostic tests were performed.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with hypersensitivity to pineapple and to amoxicillin, and a history of urticaria 5 years ago to a tetanus toxoid, who on 23-AUG-2007 was vaccinated IM with a 0.5ml first dose of Gardasil (lot # 658488/0930U). Concomitant therapy included SYNTHROID, ORTHO TRI-CYCLEN LO, albuterol, ADVAIR, CLARITIN and ZANTAC. On 23-AUG-2007 the patient experienced hives all over her body and had no trouble breathing. The patient telephoned the office and BENADRYL was prescribed. The patient's hives all over her body persisted. No laboratory or diagnostic tests were performed. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a registered nurse concerning a 19 year old female patient with hypersensitivity to pineapple and to amoxicillin, and a history of urticaria 5 years ago to a tetanus toxoid who on 23-AUG-2007 was vaccinated IM with a first 0.5ml dose of GARDASIL (lot # 658488/0930U). Concomitant therapy included SYNTHROID, ORTHO TRI-CYCLEN LO, albuterol, ADVAIR, CLARITIN and ZANTAC. On 23-AUG-2007, the patient developed hives all over her body but had no trouble breathing. The patient telephoned the office and BENADRYL was prescribed. No laboratory or diagnostic tests were performed. The patient's hives all over her body persisited. Follow up information states that this reaction was not related to the immunization. No product quality complaint was involved. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 22 year old female who in July 2007, was vaccinated with the last dose of Gardasil in the series.  Concomitant therapy included "OCT".  In January 2007 the patient tested negative for HPV.  In August 2007, the patient tested positive for HPV.  The patient sought unspecified medical attention.  The patient believed it was related to vaccination with Gardasil.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil.  The patient developed a swollen gland under her arm two weeks after receiving a dose of Gardasil.  As of 30-AUG-2007, the outcome of the patient's swollen gland was unknown.  The patient sought medical attention.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dyspnoea, Throat tightness, Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 28-AUG-2007 was vaccinated with the second dose of Gardasil.  On 29-AUG-2007 the patient experienced hives, had a really bad stomach ache, throat was tight and had trouble breathing, and by the next day had hives all over.  The patient sought unspecified medical attention.  The patient's hives, really bad stomach ache, and tight throat, and breathing trouble persisted.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Unspecified medical attention was sought. The patient's hives, really bad stomach ache, and tight throat, and breathing trouble persisted. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 22 year old female with no drug allergies and no medical history, who on 28-AUG-2007 was vaccinated intramuscularly into the right deltoid with a 0.5mL first dose of Gardasil (Lot #0469U). There was no concomitant medication. There were no illnesses at the time of the vaccination. On 29-AUG-2007 the patient woke up in the morning and noticed, raised, red spots "all over body" (arms, legs, buttocks, stomach and back) (also reported as developed hives on her arms, legs, back and abdomen) totaling 10-12 lesions (also reported as hives), with severe itching, and no difficulty breathing. On 30-AUG-2007 she called the nurse practitioner and was treated with BENADRYL. The patient was advised to not receive any further doses of GARDASIL. No laboratory diagnostics were performed. At the time of the report, the patient's outcome was unknown (previously reported as the patient had not recovered). No product quality complaint was involved. Additional information has been requested. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: DTAP, HEPA, HPV4, MNQ
Symptoms: Inappropriate schedule of drug administration, Physiotherapy, Syncope, Tooth injury, Whiplash injury
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on approximately 13-AUG-2007 was vaccinated intramuscularly with a first dose of Gardasil.  Concomitant suspect vaccination included Vaqta (dose not reported).  Concomitant vaccinations included DTaP and MENACTRA.  Subsequently, the patient fainted and as a result had whiplash and broke her front teeth.  It was reported that since the patient had received multiple vaccines, when the physician administered Gardasil she did so slowly and cautiously and the patient fainted when the physician withdrew the needle.  The patient had dental repair and went to physical therapy for the whiplash.  The patient was also treated with unspecified muscle relaxers.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a health professional concerning a 15 year old female with no medical history and no drug allergies, who on 08-AUG-2007 at 13:35 was vaccinated intramuscularly in the left deltoid with a first dose of GARDASIL vaccine (Lot# 655620/0171U). Concomitant suspect vaccination included a first dose of hepatitis A vaccine (inactive (Lot# 6580/0495U) administered intramuscularly in the right deltoid. Concomitant vaccination included a first dose of of diptheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot# AC528008) administered intramuscularly in the left deltoid and a first dose of MENACTRA vaccine (Lot# U2358AA) administered intramuscularly. There were no illnesses at the time of vaccinations. On 08-AUG-2007 the patient experienced vasovagal syncope, fainted, fell from examination table and as a result had a whiplash and broke her front teeth. It was reported that since the patient had received multiple vaccines, when the physician administered GARDASIL vaccine she did so slowly and cautiously and the patient fainted when the physician withrew the needle. The patient went to the emergency room. The patient had dental repair and went to physical therapy for the whiplash. The patient was also treated with unspecified muscle relaxers. No laboratory diagnostics were performed. At the time of the report. The patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Confusional state, Dizziness, Injection site pain, Nausea
Clinical narrative: Information has been received from a physician concerning an 11 year old female with no drug allergies and no medical history, who on 12-JUL-2007 was vaccinated with a first dose of Gardasil (Lot# 658100/0525U).  Concomitant therapy included ADACEL.  On 13-JUL-2007 the patient experienced confusion, dizziness, nausea and pain at the injection site.  The patient received each of the vaccines in different arms.  It was reported that she only experienced pain in the arm she was vaccinated with Gardasil.  The patient sought unspecified medical attention.  No laboratory diagnostics were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Dizziness, Nausea
Clinical narrative: Information has been received from a nurse concerning an 11 year old female who on an unspecified date was vaccinated with a 0.5 ml first dose of Gardasil.  Concomitant therapy included MENACTRA.  Subsequently, the patient experienced dizziness, nausea, and abdominal pain.  The symptoms lasted for "a day" and the patient recovered.  She did not report the event at the time of the occurrence.  On 29-AUG-2007 she was vaccinated with a second dose of Gardasil.  "The office is trying to follow-up with the patient to see if she had the same experience after the second dose of Gardasil, but no contact has been made yet".  There were no laboratory or diagnostic tests performed.  The patient was seen in the office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a "14 or 15" year old female who was vaccinated with a dose of Gardasil.  Subsequently the patient developed pain at the injection site and headache.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning an 11 year old female patient who on 28-AUG-2007 was vaccinated IM with a second dose of Gardasil.  The reporter reported that patient had hives on 30-AUG-2007 for which BENADRYL was recommended.  No further information was available.  The outcome was unknown.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 21 year old female with no drug allergies, who on 17-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (Lot# 657622/0388U). Subsequently, the patient developed a rash from her shoulders to her neck (previously reported as shoulders to her face.) The patient notified the physician's office when she went there for the second dose of GARDASIL. The second dose was never given to the patient. At the time of the report, the patient's outcome was unknown. Additional information has been requested. The patient recovered on an unspecified date. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Paraesthesia
Clinical narrative: Information has been received from a health professional concerning her sister who was vaccinated with Gardasil (Lot # and date not reported).  The patient experienced soreness and tingling three days after receiving Gardasil.  As of 30-AUG-2007, the outcome of the patient's soreness and tingling was unknown.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a physician concerning an approximately 14 year old female who was vaccinated with Gardasil.  Subsequently, the patient developed a headache and pain at injection site that radiated to the back of her shoulder and to the back of her neck.  Subsequently, the patient recovered from the headache and the pain at injection site that radiated to the back of her shoulder and to the back of her neck.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Metrorrhagia
Clinical narrative: Information has been received from a nurse and a medical assistant concerning a female patient who was vaccinated IM with a dose of Gardasil. Concomitant therapy included antimicrobial (unspecified). The reporter reported that patient received Gardasil and her period stopped for 2 months, the patient only had a little bit of spotting for the 2 months. As of this report day patient has not recovered. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Chloasma, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse concerning a 27 year old female who in approximately February 2007, "6 months ago" was vaccinated with a first dose of Gardasil (lot # unknown).  Concomitant therapy included hormonal contraceptives (unspecified) for 5 years.  On an unspecified date the patient was vaccinated with a second dose of Gardasil.  On an unspecified date the patient was vaccinated with a third dose of Gardasil 0.5 mL injection.  The patient came into the office and said she developed melasma (brown spots on her face).  Medical attention was sought.  At the time of reporting the patient's melasma persisted.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood pressure, Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 30-AUG-2007 was vaccinated with Gardasil (Lot # not provided).  On 30-AUG-2007 post vaccination the patient experienced numbness in her arm that radiated and then numbness in her other arm.  The numbness then turned to pain.  It was reported that the patient also felt weak.  The patient's blood pressure was recorded at 80/60 mmHg which was reported to be slightly higher than before she felt weak.  Unspecified medical attention was sought.  At the time of the report it was reported that the patient was recovering.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Swelling
Clinical narrative: Information has been received from a physician concerning his sister who on an unspecified date was vaccinated with Gardasil (Lot # not provided).  Subsequently, she developed a rash that was itchy and swelling.  Unspecified medical attention was sought.  At the time of this report it was unknown if she had recovered from the event.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Information has been received from an unspecified source who reported that a 17 year old female with shellfish intolerance, decreased hearing in the right ear and who required glasses to see distant objects on 30-AUG-2007 received her second dose of Gardasil 0.5 ml, intramuscularly.  It was the patient's second dose of Gardasil 0.5 ml, intramuscularly.  The date of the patient's first dose and lot numbers were not known.  There were no concomitant medications.  On 30-AUG-2007 the patient experienced pain at the injection site in her left arm.  On approximately 30-AUG-2007 the patient experienced knee pain.  On approximately 02-SEP-2007 the patient recovered from the pain at the injection site.  On 03-SEP-2007 the knee pain resolved.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a physician concerning a female with an allergy to "tetanus shot" who was vaccinated with the first dose of Gardasil.  On 24-AUG-2007, the patient experienced an allergic reaction described as hives.  The patient's hives persisted.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from an office manager concerning a 15 year old female with a penicillin allergy who on 31-JUL-2007 was vaccinated with Gardasil.  There was no concomitant medication.  Two days after vaccination, on 02-AUG-2007, the patient developed tremors of the hands and feet.  The symptoms lasted for six days.  The patient came to the office on 25-AUG-2007 to report the tremors.  As of 31-AUG-2007 the patient had no symptoms.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007.  Initial and follow-up information has been received from an office nanager concerning a 15 year old female student with PENICILLIN allergy and no medical history, who on 31-JUL-2007 at 16:30 was vaccinated intramuscularly in the upper arm with a first dose of GARDASIL (Lot# 658222/0927U).  There was no concomitant medication. Two days after vaccination, on 02-AUG-2007, the patient developed tremors of the hands and feet.  The symptoms lasted for about six days.  The patient came to the office on 25-AUG-2007 to report the tremors.  At the time of the office visit the patient had no symptoms.  There was no ataxia, or dizziness (previously reported as of 31-AUG-2007 the patient had no symptoms).  No laboratory diagnostic studies were performed.  No product quality complaint was involved.  At the time of this report, the patient had recovered.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Lymphadenopathy, Sinusitis
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on approximately 24-AUG-2007 was vaccinated with her first dose of Gardasil in her right arm.  Concomitant therapy included MENACTRA and BOOSTRIX in the left arm.  On 31-AUG-2007 the patient came into the office reporting a sinus infection and the physician identified swollen lymph nodes in her neck and right axillary area.  As of 31-AUG-2007, the patient's sinus infection and swollen lymph nodes in her neck and right axillary area persisted.  Patient Quality Complaints (PQC) was not involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007.  Information has been received from a physician concerning a 16 year old female who on approximately 24-AUG-2007 was vaccinated with her first dose of GARDASIL in her right arm.  Concomitant therapy included MENACTRA and BOOSTRIX in the left arm.  On 31-AUG-2007 the patient came into the office reporting a sinus infection and the physician identified swollen lymph nodes in her neck and right axillary are (also reported as axillary lymph nodes on the right arm 3-4 days after vaccination).  AS of 31-AUG-2007, the patient's sinus infection and swollen lymph nodes in her neck and right axillary area persisted.  Patient Quality Complaints (PQC) was not involved.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test normal, Dizziness, Headache, Vision blurred
Clinical narrative: Information has been received from a nurse concerning an 18 year old female waitress with a history of panic attack and anxiety issues who on 21-MAY-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  Concomitant therapy included REMERON, LAMISIL and LAMICTAL.  On 19-JUN-2007 the patient experienced multiple episodes of dizziness.  It was reported on one occasion she felt light-headed, weak, blurry vision and headache while working a 12 hour shift.  She was taken to the emergency room.  In June 2007 the patient had a physical and blood work which were normal.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007.  Initial and follow up information has been received from a nurse and a healthcare professional (HCP), concerning an 18 year old female waitress with a history of panic attack and anxiety issues, who on 21-MAY-2007 at 4:00 pm, was vaccinated in the right deltoid, with a 0.5 ml, first dose of GARDASIL (lot #657622/0388U).  Concomitant therapy included REMERON, LAMASIL and LAMICTAL.  There was no illness at the time of vaccination.  On approximately 04-JUN-2007 ("two weeks later").   She "started having syncope."  On 19-JUN-2007 the patient experienced multiple episodes of dizziness.  It was reported on one occasion she felt light-headed, weak, blurry vision and headache while working a 12 hour shift.  She was taken to the emergency room.  In June 2007 the patient had a physical and blood work which were normal.  The HCP indicated the syncope lasted for up to a month, and required visits to the ER and office;  she indicated the patient had recovered on 09-JUL-2007.  The HCP added the patient had not received the second vaccination, since "she will be going to college."  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a certified medical assistant concerning a 26 year old female with no drug allergies and no medical history, who on 13-AUG-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 658488/0930U).  There was no concomitant medication.  Subsequently, "within a few days" the patient developed small bumps all over her back.  It was not itchy.  The patient picked at it and thought they were pimples.  She treated the bumps with PROACTIVE.  No laboratory diagnostics were performed.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  It was reported that the bumps had gotten worse over time.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Dizziness, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 13-JUN-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  On 14-AUG-2007 the patient was vaccinated with a 0.5 ml second dose of Gardasil (Lot # 658282/0929U).  Concomitant medication included MENACTRA.  On 14-AUG-2007 the patient's family member called the office and reported that the patient felt dizzy and was acting loopy after the second dose.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  She did not report a similar experience after the first dose.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Dizziness
Clinical narrative: Information has been received from a nurse, via a company representative, concerning a 23 year old ("about 23 years old") female patient, who on 13-JUN-2007 was vaccinated with the first dose of Gardasil with no difficulties reported, and on 14-AUG-2007, was vaccinated with the second dose, 0.5 ml, of Gardasil (lot #658282/0929U).  Concomitant therapy included ADACEL.  On 14-AUG-2007, following the second vaccination, a family member called the office to report the patient felt dizzy and was "acting loopy."  Subsequently, the patient recovered (date and duration not specified).  The patient's 14 year old sister also experienced a similar event as described above, when vaccinated with Gardasil (lot #658282/0929U) (WAES # 0709USA00082).  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female who, on an unspecified date, was vaccinated with a first dose of Gardasil.  Subsequently, the patient fainted.  The patient sought unspecified medical attention.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 19 year old female who in June 2007, was vaccinated on the left arm with a first dose of Gardasil.  In June 2007 the patient developed a rash that went all the way down the patient's left arm, down her upper back and down the right arm.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the rash.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Initial and follow up information has been received from a nurse concerning a female between the ages of 13 to 16 years old, who was vaccinated intramuscularly with a dose of Gardasil (Lot# 654741/1208F).  Subsequently, after receiving the vaccination the patient fainted.  At the time of the report, the patient's outcome was unknown.  The same source provided information on another patient, WAES #0707USA01794 and WAES# 0707USA05068.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated with a second dose of Gardasil in her left arm.  Subsequently, the patient felt dizzy as she started to walk to the bathroom.  She became even more dizzy she decided to sit down on the floor and she fainted.  The patient was not injured she didn't hit her head.  The patient was placed in a supine position where cold rags were applied.  It was reported that the patient rested for a while.  The patient recovered from that event. This is in follow-up to report(s) previously submitted on 9/12/2007.  Information has been received from a physician concerning a 13 year old female who was vaccinated with a second dose of GARDASIL in her left arm.  Subsequently the patient felt dizzy as she started to walk to the bathroom.  She became even more dizzy she decided to sit down on the floor and then fell over.  The patient was not injured she didn't hit her head or loose conciousness.  The patient was placed in a supine position for the 25 minutes during Pulse and BP were normal.  Cold rags were applied.  It was reported that the patient rested for a while and left with her father.  The patient admitted to being fasting since 26-Aug-2007, 7:00PM.  The patient recovered from that event.  No product quality complaint was involved.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Headache
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 31-AUG-2007 was vaccinated with a first dose of Gardasil.  Illness at time of vaccination included headache.  There was no concomitant medication.  Fifteen minutes after receiving the first dose of Gardasil she still had a pretty bad headache.  No hospitalization or medical treatment was required.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who was vaccinated with the third dose of Gardasil (Lot #658222/0927U) on 21-AUG-2007. On approximately 21-AUG-2007, the patient complained of a headache with a short duration after the third dose of Gardasil.  This is one of three reports from the same source/siblings.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who was vaccinated with the third dose of Gardasil (Lot #658222/0927U) on 21-AUG-2007. On approximately 21-AUG-2007, the patient complained of a headache with a short duration after the third dose of Gardasil.  This is one of three reports from the same source/siblings.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female who on an unspecified date was vaccinated intramuscularly with Gardasil (0.5 ml) (Lot # 658094/0524U).  Subsequently, following vaccination, the patient fainted.  Unspecified medical attention was sought. It was noted that the nurces are having patients lay down prior to administration of the vaccine.  The patient subsequently recovered.  The nurse reported that the patient has had no problems since this incident.  Additional information has been requested.  This is one of two reports from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician assistant concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient fainted.  The patient recovered before leaving the office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hepatic enzyme abnormal, Liver function test abnormal
Clinical narrative: Information has been received from a physician concerning a female who on 29-MAY-2007 was vaccinated with Gardasil.  On 20-JUN-2007, lab work was done as part of a regular check-up, and transient elevated liver enzymes was noted.  It was reported that the rest of the lab work was normal, and there was no elevation in bilirubin.  The patient was re-tested 3 weeks later, and all results were normal.  The patient was reported to be fine.  Additional information has been requested.  This is one of two repots from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a female 20 years of age or younger with no pertinent medical history who was vaccinated with Gardasil.  There was no concomitant medication.  Subsequently the patient experienced influenza-like symptoms (headache, some nausea, vomiting and myalgia) within 24 hours of receiving her first dose of Gardasil.  The patient possibly had a CPK level that was mildly elevated (values not reported).  The patient was possibly examined in the emergency room but was not admitted.  Subsequently, the patient's symptoms resolved within one to four days.  Unspecified medical attention was sought.  Patient Quality Complaints (PQC) was not involved.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil.  Subsequently the patient experienced numbness in her arm and axilla.  No patient could be identified, and at the time the numbness was not associated with the Gardasil vaccination.  Subsequently she recovered without treatment after a few days.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a medical assistant concerning a female patient who was vaccinated IM with a dose of Gardasil.  Concomitant therapy included antimicrobial (unspecified).  The reporter mentioned that patient's menstruation period stopped for 1 month then came back after she got the dose of Gardasil.  She also mentioned that the patient was not pregnant.  The outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: Information has been received from a nurse and a medical assistant concerning a female patient who was vaccinated IM with a dose of Gardasil.  Concomitant therapy included antimicrobial (unspecified).  The reporter reported that the patient did not have her period for 2 months.  Her pregnancy test was negative.  The patient's grand mother mentioned that it was unknown whether the patient has a history of irregular menstrual periods.  The outcome was unknown.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Injection site pain, Musculoskeletal stiffness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient in her 20's who was vaccinated with a first and second dose of Gardasil. The physician reported that the patient had unusual soreness at the injection site after the first and second injection. He also reported that the patient had unusual stiffness and weakness with local mechanical trouble after she was given the third dose of Gardasil. The patient had not recovered as of this report day. The physician reported that this is one of the three patient who experienced similar experience. Additional information is not expected.