chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug hypersensitivity, Formication, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with no known drug allergies and no past medical history who on 21-Jan-2008 was vaccinated with her first dose of GARDASIL (lot# 659964/1978U, site and route not reported). The patient experienced a creep, crawly insect under the skin feeling all over her body and systemically. No associated rash, however it was itchy. No wheezing, no cough and spontaneously resolved by itself with no treatment. The patient received the second dose of GARDASIL (lot# unspecified, site and route not reported) on 27-MAR-2008. Subsequently, the reaction occurred more quickly and they gave her Allegra, an allergy medication to try and calm things down. Concomitant therapy included LEVLEN (30 mg estrogen and 0.15 progesterone). The patient experienced feeling of creep, crawly insect under skin and itchy. The patient recovered from feeling of creep, crawly insect under skin and itching feeling. No additional information was provided. Additional information has been requested. 02/17/2010 Follow up information received indicated that the patient who has an allergy to Penicillin was vaccinated IM in her left deltoid with her second dose of GARDASIL (lo# 659964/1978U) on 27-Mar-2008 at 2:00 p.m. Thirty minutes post vaccination, the patient described a felling of "crawling" sensation under her skin and itching all over her body. Patient had no rash, no shortness of breath and no tightening of airways. Patient was given an antihistamine and was observed in the office for more than an hour while symptoms resolved. The patient indicated she had similar reaction with the first dose. The patient's vital signs remained normal. The patient's status was reported as recovered. No further information is expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Antinuclear antibody negative, Arthritis, Blood creatine phosphokinase normal, C-reactive protein increased, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a female with a history of depression who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported). Concomitant therapy included ZOLOFT. On approximately 06-MAR-2008 the patient experienced transient inflammatory arthritis. The patient was prescribed a MEDROL dose-pack by her physician. A complete blood count, metabolic panel and creatine phosphokinase were normal. Antinuclear antibody and rheumatoid factor were negative. Sed rate was elevated to 65 and C-reactive protein was elevated to 24.6. A doppler study of the lower extremities was normal. Subsequently, the patient recovered from transient inflammatory arthritis. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Inflammation, Laboratory test normal, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Ultrasound scan normal
Clinical narrative: Information has been received from a physician concerning a female with a history of depression who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported). Concomitant therapy included ZOLOFT. On approximately 06-MAR-2008 the patient experienced transient inflammatory arthritis. The patient was prescribed a MEDROL dose-pack by her physician. A complete blood count, metabolic panel and creatine phosphokinase were normal. Antinuclear antibody and rheumatoid factor were negative. Sed rate was elevated to 65 and C-reactive protein was elevated to 24.6. A doppler study of the lower extremities was normal. Subsequently, the patient recovered from transient inflammatory arthritis. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Blood test, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician concerning a female with a history of depression who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported). Concomitant therapy included ZOLOFT. On approximately 06-MAR-2008 the patient experienced transient inflammatory arthritis. The patient was prescribed a MEDROL dose-pack by her physician. A complete blood count, metabolic panel and creatine phosphokinase were normal. Antinuclear antibody and rheumatoid factor were negative. Sed rate was elevated to 65 and C-reactive protein was elevated to 24.6. A doppler study of the lower extremities was normal. Subsequently, the patient recovered from transient inflammatory arthritis. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, C-reactive protein increased, Oedema peripheral, Red blood cell sedimentation rate increased, Streptococcal identification test positive
Clinical narrative: Information has been received from a physician concerning a female with a history of depression who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported). Concomitant therapy included ZOLOFT. On approximately 06-MAR-2008 the patient experienced transient inflammatory arthritis. The patient was prescribed a MEDROL dose-pack by her physician. A complete blood count, metabolic panel and creatine phosphokinase were normal. Antinuclear antibody and rheumatoid factor were negative. Sed rate was elevated to 65 and C-reactive protein was elevated to 24.6. A doppler study of the lower extremities was normal. Subsequently, the patient recovered from transient inflammatory arthritis. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated on an unspecified date and her first dose of GARDASIL (lot# not reported). Subsequently the patient experienced hives all down her arm. She sought unspecified medical attention and her outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: C-reactive protein normal, Chest discomfort, Computerised tomogram normal, Epstein-Barr virus test negative, Fatigue
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 11-FEB-2008 was vaccinated with her first dose of Gardasil (lot# not reported). Subsequently the patient experienced fatigue, malaise and chest tightness at an unspecified time which lasted for several days. The patient went to a cardiologist where she had a full work up. The following tests were normal: Epstein-Barr, CRP, chem panel, MRI and CAT scan. The patient did test positive for Juvenile Rheumatoid Arthritis. The patient's outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Juvenile arthritis, Laboratory test normal, Malaise, Nuclear magnetic resonance imaging normal, Rheumatoid factor positive
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 11-FEB-2008 was vaccinated with her first dose of Gardasil (lot# not reported). Subsequently the patient experienced fatigue, malaise and chest tightness at an unspecified time which lasted for several days. The patient went to a cardiologist where she had a full work up. The following tests were normal: Epstein-Barr, CRP, chem panel, MRI and CAT scan. The patient did test positive for Juvenile Rheumatoid Arthritis. The patient's outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on approximately 21-FEB-2008, "about three weeks ago" was vaccinated with an unspecified dose of GARDASIL (lot number unspecified).  The patient fainted.  The patient came to and was fine.  The lot number was unknown.  The patient recovered.  No further information was provided.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who, on an unspecified date, was vaccinated with her first dose of GARDASIL (Lot # and site not reported).  The patient experienced redness and itching around the injection site.  On an unspecified date the patient was vaccinated with her second dose of GARDASIL (Lot # and site not reported).  Subsequently the patient experienced redness, itching, and hives following her second dose of GARDASIL.  The patient sought unspecified medical attention.  Additional information has been requested.   This is in follow-up to report(s) previously submitted on 4/14/2008.  Follow-up information received on 05-MAY-2008 from the physician reported that the office has no information.  The experiences was brought to their attention by the patient's father after the fact and there was "no objective findings".  No additional information was reported.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who, on an unspecified date, was vaccinated with her first dose of GARDASIL (Lot # and site not reported).  The patient experienced redness and itching around the injection site.  On an unspecified date the patient was vaccinated with her second dose of GARDASIL (Lot # and site not reported).  Subsequently the patient experienced redness, itching, and hives following her second dose of GARDASIL.  The patient sought unspecified medical attention.  Additional information has been requested.   This is in follow-up to report(s) previously submitted on 4/14/2008.  Follow-up information received on 05-MAY-2008 from the physician reported that the office has no information.  The experiences was brought to their attention by the patient's father after the fact and there was "no objective findings".  No additional information was reported.  Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Laboratory test, Liver function test
Clinical narrative: Information has been received from a physician concerning a 24 year old female with endometriosis and a history of acne who on 13-SEP-2007 was vaccinated with her first dose of GARDASIL (lot # and route not provided). On 13-NOV-2007, the patient was vaccinated with her second dose of GARDASIL (lot # and route not provided). On about 13-DEC-2007 (about one month after the second vaccination), the patient developed joint pain and muscle aches. A mild elevation of liver enzymes AST and ALT were noted during laboratory test (dated and results unspecified) following the joint pain and muscle aches. The patient underwent various blood test (not further specified and results not reported). On 13-Mar-2008, the patient was vaccinated with her third dose of GARDASIL (lot # and route not provided). Concomitant therapy included AYGESTIN, minocycline (unspecified) and RETIN-A. The patient underwent a number of blood tests and liver function tests to rule out hepatitis by her primary physician (tests, results and primary physician not specified). The patient sought unspecified medical attention. The joint pain and muscle aches are continuing, but have improved at the time of this report. No other information was reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a physician concerning a 24 year old female with endometriosis and a history of acne who on 13-SEP-2007 was vaccinated with her first dose of GARDASIL (lot # and route not provided). On 13-NOV-2007, the patient was vaccinated with her second dose of GARDASIL (lot # and route not provided). On about 13-DEC-2007 (about one month after the second vaccination), the patient developed joint pain and muscle aches. A mild elevation of liver enzymes AST and ALT were noted during laboratory test (dated and results unspecified) following the joint pain and muscle aches. The patient underwent various blood test (not further specified and results not reported). On 13-Mar-2008, the patient was vaccinated with her third dose of GARDASIL (lot # and route not provided). Concomitant therapy included AYGESTIN, minocycline (unspecified) and RETIN-A. The patient underwent a number of blood tests and liver function tests to rule out hepatitis by her primary physician (tests, results and primary physician not specified). The patient sought unspecified medical attention. The joint pain and muscle aches are continuing, but have improved at the time of this report. No other information was reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia areata
Clinical narrative: Information has been received from a nurse concerning a 16 year old female who sometime in October 2007, was vaccinated with the first dose of Gardasil (lot number not reported). Concomitant therapy included SINGULAIR, VENTOLIN and ZYRTEC. In October 2007, the patient experienced losing her hair and was diagnosed with "alopecia ariat". On an unspecified date the patient has received the second dose of Gardasil (lot number not reported). The patient is still experiencing hair loss and currently receives steroid injections in her head every six weeks. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with GARDASIL (lot number not provided).  Subsequently the patient experienced fever, nausea and diarrhea.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous, Rash macular, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female with a history of anaemia who on 28-FEB-2008 was vaccinated intramuscularly in the left deltoid with her first dose of Gardasil (Lot # reported as 1758O).  About 2 days after the vaccination, the patient developed a rash on her abdomen, chest and shoulder.  There was no shortness of breath, no hives, no fever or no other symptoms.  The patient sought unspecified medical attention in the office.  No other information is available.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has beenreceived from a nurse practitioner concerning a 14 year old female with a history of anaemia, and no know allergies, who on 28-FEB-2008 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot # reported as 1758O). On 02-Mar-2008, about 2 days after the vaccination, the patient developed erythematous macular-papular eruption on her abdomen, chest and shoulders. It was minimally pruritic. There was no shortness of breath, no hives, no fever or no othersymptoms. On 12-MAR-2008, the patient was seen for evaluation of the rash for the first time. The patient was given CLARITIN and hydrocortisone cream (not specified). On 14-MAR-2008, two days later, the rash cleared. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Cystitis, Drug exposure during pregnancy, Premature labour
Clinical narrative: Information has been received through an agency from a nurse and physician concerning a 16 year old female with drug hypersensitivity (Hydrocodeine) and a history of asthma, selective IgA subclass deficiency, and severe bladder infection, who on 18-JUL-2007 was vaccinated intramuscularly with a 0.5 ml of her first dose of GARDASIL (lot#655620/0171U).  Concomitant suspect therapy included DTaP.  On an unspecified date in October 2007, the patient found out she was pregnant (LMP not reported).  The specific pregnancy test and date it was performed, were not reported.  In the follow-up information it was reported, that the patient had developed a severe bladder infection and was restricted to bed rest because of preterm labor.  Unspecified medical attention was sought by calling doctor's office.  At the time of this report it was unknown if the patient had recovered from her experiences.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  Information has been received from a licensed practical nurse (L.P.N.) for the pregnancy registry for GARDASIL concerning a 16 year old female with a drug hypersensitivity to Hydrocodeine and asthma and a history of IgA deficiency.  On 18-JUL-2007, the patient was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (lot#055620/0171U).  Concomitant therapy included a dose of DTaP.  On an unspecified date in October 2007, the patient found out she was pregnant (LMP not reported).  The specific pregnancy test and date it was performed, were not reported.  Follow up information was received from the L.P.N. reporting that the patient last menstrual period (LMP) was 25-SEP-2007.  During pregnancy, on an unspecified date the patient experienced a urinary tract infection (UTI).  In February 2008, the patient took AUGMENTIN 850 mg twice a day for the treatment of UTI.  At 19 weeks of gestation, on approximately 08-Feb-2008 the patient experienced premature labor.  In April 2008 and in December "2008" the patient took "tribuatoline 2.5 mg every 4 hours"  and "vistoril 25 mg every 4 hours" for the treatment of premature labor, respectively.  The date of live birth was 12-JUN-2008, which was 36 weeks from LMP.  The infant was a normal male whose Apgar score was 5/9 without any congenital anomalies.  He weighed 6lb 5oz. length 17.5 inches, head circumference 33 cm.  No further information is expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 13 years old daughter who on approximately 30-AUG-2007 was vaccinated with her first dose of Gardasil (lot# unspecified).  There was no concomitant medication.  Approximately one week later the patient began experiencing dizziness and vomiting.  It was reported that initially she experienced the dizziness and vomiting at least once a week and then once every couple of months.  Unspecified medical attention was sought.  At the time of this report, the patient was still recovering from her experience.  No additional information was provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a physician and a consumer concerning her 12 years old daughter with allergic rhinitis and no known drugs allergies who on 22-AUG-2007 was vaccinated in the left deltoid with her first dose of GARDASIL (lot# 658222/0927U). Unspecified medical attention was sought when patient's mother called the physician's office on 27-Aug-2007 regarding the patient's complaint of headache, nausea and dizziness. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician concerning a female who on 14-JAN-2008 was vaccinated "by injection" with Gardasil (lot # not reported). Subsequently the patient developed a knot at injection site. The patient sought unspecified medical attention. Therapy with Gardasil vaccine was discontinued. The knot at the injection site persisted. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 01-DEC-2007 was vaccinated 0.5mL, IM with Gardasil (Lot# not reported).  Following her vaccination the patient experienced flu like symptoms that lasted about 3 days.  Subsequently, the patient recovered from flu like symptoms.  The patient sought unspecified medical attention at her physician's 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 with anxiety who on an unspecified date was vaccinated intramuscularly with a third dose of Gardasil from a single dose vial (lot # not reported). The physician reported that after receiving the third dose of Gardasil, "almost immediately", the patient experienced dizziness. The patient sought unspecified medical attention. It was reported that "the patient is fine." Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who on 13-MAR-2008 was vaccinated intramuscularly with her second and third dose of Gardasil (lot number not provided).  On 13-MAR-2008 the patient fainted after administration.  Subsequently, the patient recovered from fainted.  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Muscle spasms, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 29-FEB-2008 was vaccinated with GARDASIL (lot number not specified).  Concomitant therapy included MENACTRA given in one arm and PEDIARIX given in the same arm as the GARDASIL.  The patient had a reaction in the arm the MENACTRA was given (unspecified if it was the right or left arm).  On 29-FEB-2008 the patient experienced uncontrolled spasms in fingers and tingling in fingers.  The reaction has now stopped getting worse and the physician feels the patient is recovering.  The physician feels that could be due to any of these vaccines although GARDASIL was not given in this arm.  The patient sought medical attention and is being treated with FLEXERIL and ATIVAN.  No other information is available.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  Additional follow up information indicated the vaccinations were done in Arizona.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Mass, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who "a month ago" approximately in February 2008, was vaccinated 0.5mL with Gardasil (lot# not reported). Concomitant therapy included MENACTRA (lot# not reported) in the same arm. Subsequently, the patient developed a lump in her arm and soreness up and down her arm. It was not reported if these symptoms occurred immediately or within days after vaccination. The patient recovered from the lump in her arm and soreness up and down her arm. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, C-reactive protein, Epstein-Barr virus antibody negative, Fatigue
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female with a history of an spleen enlarged and a penicillin allergy who on 05-FEB-2008 was vaccinated intramuscularly with Gardasil (Lot # 659962/1740U).  There was no concomitant medication.  On 03-MAR-2008 the patient began experiencing body aches, belly pain and extreme fatigue.  On unspecified date, the patient had an ultrasound, a complete blood cell count (CBC), a serum C-reactive protein test (CRP), and an Epstein-Barr virus antibodies screen; however, no results were reported.  The patient sought unspecified medical attention by being seen in the office.  At the time of this report, the patient's body aches and belly pain and extreme fatigue have persisted.  No additional information was provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  Follow-up information received 25-MAR-2008 from the licensed practical nurse, reported that the patient had modest splenomegaly with abdominal pain, sweats, no fever, no pruritis noted approximately 4 weeks after receiving the first dose of GARDASIL.  Patient "worked up for possible mono, EAV (-)".  On 10-MAR-2008, the patient had an ultrasound that showed enlarged spleen (previously reported as medical history).  On 17-MAR-2008, the patient was seen and still had abdominal pain.  Follow-up information received 07-APR-2008 from the nurse practitioner reported "Patient was back to normal." Office thinks might have been viral syndrome." "Labs and CBC followed" (no results reported).  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count, Hyperhidrosis, Pain, Splenomegaly, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female with a history of an spleen enlarged and a penicillin allergy who on 05-FEB-2008 was vaccinated intramuscularly with Gardasil (Lot # 659962/1740U).  There was no concomitant medication.  On 03-MAR-2008 the patient began experiencing body aches, belly pain and extreme fatigue.  On unspecified date, the patient had an ultrasound, a complete blood cell count (CBC), a serum C-reactive protein test (CRP), and an Epstein-Barr virus antibodies screen; however, no results were reported.  The patient sought unspecified medical attention by being seen in the office.  At the time of this report, the patient's body aches and belly pain and extreme fatigue have persisted.  No additional information was provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  Follow-up information received 25-MAR-2008 from the licensed practical nurse, reported that the patient had modest splenomegaly with abdominal pain, sweats, no fever, no pruritis noted approximately 4 weeks after receiving the first dose of GARDASIL.  Patient "worked up for possible mono, EAV (-)".  On 10-MAR-2008, the patient had an ultrasound that showed enlarged spleen (previously reported as medical history).  On 17-MAR-2008, the patient was seen and still had abdominal pain.  Follow-up information received 07-APR-2008 from the nurse practitioner reported "Patient was back to normal." Office thinks might have been viral syndrome." "Labs and CBC followed" (no results reported).  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 21 year old female who was vaccinated "by injection" with a second dose of Gardasil (lot # not reported).  "Last week", on approximately 07-MAR-2008 the patient developed an itchy rash at the injection site.  The patient sought unspecified medical attention and was given Benadryl to stop the itching.  Subsequently, the patient recovered from the itchy rash at the injection site.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning her relative, a 23 year old female who in January 2008, was vaccinated with her second dose of Gardasil (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). In March 2008, the patient experienced shingles on trunk. She was seen by her physician and is being treated with VALTREX. The patient was recovering from shingles on her trunk. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal human papilloma virus infection
Clinical narrative: Information has been received from a health professional concerning a female who on 27-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (lot # reported as "1266").  On 27-FEB-2008 the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil (lot # reported as "1266").  There was no concomitant medication.  On approximately 29-FEB-2008, "about two weeks ago", the patient noticed that she developed vaginal warts.  No other symptoms and treatment were reported.  The patient sought unspecified medical attention during an office visit.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a certified medical assistant and a physician concerning a female who on 27-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # reported as "1266"). On 27-FEB-2008 the patient was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL (lot # reported as "1266"). There was no concomitant medication. On approximately 29-FEB-2008, "about two weeks ago", the patient noticed that she developed vaginal warts. No other symptoms and treatment were reported. The patient sought unspecified medical attention during an office visit. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 06-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 659182/1757U) and when she walked to the front desk afterwards she fainted.  Concomitant suspect therapy included VARIVAX.  Other concomitant therapy included LOESTRIN.  The patient was given some unspecified fluids in the office and recovered from the event.  No further information provided.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Hypokinesia, Pain
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female with diabetes who on 03-MAR-2008 was vaccinated with a second dose of Gardasil IM injection in the arm. On 03-MAR-2008 after receiving her second dose of Gardasil the patient cried, could not move, became stunned and was in extreme pain. It was noted that the patient had not eaten that day. At the time of the report on an unspecified date the patient had recovered with unspecified therapy. On an unspecified date the patient had received a first dose of Gardasil. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning an approximately 12 year old female who on unspecified date was vaccinated intramuscularly with the second dose of Gardasil (lot # unspecified).  Date of 1st dose of Gardasil was not reported.  Post vaccination the patient experienced pain at the injection site for approximately one month.  The physician reported that the patient did not have this experience after the first dose.  Subsequently, on unspecified date the patient recovered from the pain at the injection site. No further information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a female with no medical history and no drug reactions/allergies, who on 14-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# unspecified). It was reported that 30 minutes after vaccination the patient had rash. Unspecified medical attention was sought by contacting physician. At the time of this report the patient was still recovering from her experience. No other information was available. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dizziness, Hyperventilation, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning an approximately 20 year old female who, on an unspecified date was vaccinated in the deltoid with her first dose of Gardasil (lot # not reported). The patient felt faint after receiving the first vaccination. On an unspecified date, the patient was vaccinated in the deltoid with her second dose of Gardasil (lot # not reported). On approximately 25-Feb-2008, also reported as "within the last 3 weeks", the patient felt both her hands and feet were numb after receiving the second dose of Gardasil. The reporter noted that the adverse event improved "on therapy" (not otherwise specified) and that the patient was recovering. The patient sought unspecified medical attention. No additional information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/14/2008. Initial and follow up information has been received forma physician and a licensed practical nurse concerning 24 year old female (142 lb; 64 inches) who, on an unspecified date was vaccinated in the deltoid with her first dose of GARDASIL (lot # not reported). The patient felt faint after receiving the first vaccination. On 28-FEB-2008, the patient was vaccinated in the right deltoid with her second dose (also reported as her third dose) of GARDASIL vaccine (Lot # 660387/1967U). On 28-FEB-2008, the patient felt became light headed and then complained of numbness in arms and legs. Her hands and arms were stiffening up. The patient was crying due to the symptoms. The patient was hyperventilating. After 20 minutes, the patient relaxed and the symptoms disappeared. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abnormal, Computerised tomogram head, Drug administered at inappropriate site, Eye injury, Fall
Clinical narrative: Information has been received from a mother, who is also a nurse, concerning her 20 year old daughter, with possible polycystic ovarian syndrome and a history of adenoidectomy as a child, who in February 2008, was vaccinated in the right gluteus with her first dose of Gardasil (lot #not reported).  The patient was lying down when she received the vaccination and the patient stated she felt "a little funny, like you hit a nerve."  The patient was told to lay there for awhile.  On 14-Mar-2008, the patient was vaccinated intramuscularly in the right arm with her second dose of Gardasil (lot # not reported) while sitting on the exam table.  There was no concomitant medication.  The patient fainted after receiving the second vaccination.  She fell to the floor and hitting her right eye on the stool.  There was a laceration of 1" above the eye.  The mother took the daughter to the ER where they glued and steristripped the laceration.  While at the ER, a Cat Scan of the head was performed with the result being positive for a possible shadow.  The patient was not hospitalized.  On 15-MAR-2008, the patient went to a different hospital for follow-up.  Another Cat Scan of the head was performed but the result were normal.  The hospital wanted to keep the patient overnight, but she refused.  The patient is scheduled to have a MRI.  The reporter stated that patient is "feeling good now".  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Laceration, Syncope
Clinical narrative: Information has been received from a mother, who is also a nurse, concerning her 20 year old daughter, with possible polycystic ovarian syndrome and a history of adenoidectomy as a child, who in February 2008, was vaccinated in the right gluteus with her first dose of Gardasil (lot #not reported).  The patient was lying down when she received the vaccination and the patient stated she felt "a little funny, like you hit a nerve."  The patient was told to lay there for awhile.  On 14-Mar-2008, the patient was vaccinated intramuscularly in the right arm with her second dose of Gardasil (lot # not reported) while sitting on the exam table.  There was no concomitant medication.  The patient fainted after receiving the second vaccination.  She fell to the floor and hitting her right eye on the stool.  There was a laceration of 1" above the eye.  The mother took the daughter to the ER where they glued and steristripped the laceration.  While at the ER, a Cat Scan of the head was performed with the result being positive for a possible shadow.  The patient was not hospitalized.  On 15-MAR-2008, the patient went to a different hospital for follow-up.  Another Cat Scan of the head was performed but the result were normal.  The hospital wanted to keep the patient overnight, but she refused.  The patient is scheduled to have a MRI.  The reporter stated that patient is "feeling good now".  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 15-JAN-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot # 658563/1063U).  There was no concomitant medication.  On 15-JAN-2008 the patient experienced severe nausea after receiving the first dose of GARDASIL.  The patient sought unspecified medical attention in the office.  On 16-Jan-2008, the patient recovered from severe nausea.  No further information is available.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a healthcare worker concerning a female who  on 31-MAY-2007 was vaccinated with her first dose of Gardasil (lot# not reported). On 17-MAR-2008 the patient was vaccinated with her second dose of Gardasil (lot# not reported) and experienced injection site pain. The patient's outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008.  Follow-up was received on 16-MAY-2008 from the office manager who indicated she does not remember reporting this event and questioned who the patient was.  No other information was available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician who heard from another physician concerning a female patient, "about 16 or 17 years old", who had received two doses of Gardasil (lot numbers not reported), went to a gynecologist with a problem, and it was diagnosed as a genital wart. It is unknown if the wart was present prior to receiving Gardasil. No product quality complaint was involved. The patient
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Gastroenteritis, Nausea, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on approximately 12-MAR-2008 was vaccinated with her first dose of GARDASIL (lot number 658556/1060U).  On approximately 12-MAR-2008 the patient experienced nausea, vomiting, diarrhea and gastroenteritis.  The symptoms began within 24 hours of vaccination.  The patient's nausea and vomiting and diarrhea and gastroenteritis persisted.  The patient sought unspecified medical treatment when her mother called the office.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Cough, Pyrexia, Respiratory tract congestion
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female who on 13-MAR-2008 was vaccinated with her third dose of GARDASIL (lot# 659653/1448U). On unspecified date the patient developed a fever of 100F, congestion, coughing. The date and lot numbers of the first two doses were not provided. Unspecified medical attention was sought by calling office. The patient was advised to take ADVIL for relief of symptoms. At the time of this report the patient did not recover from her experiences. No other symptoms or treatment reported. No other information available. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow up information has been received from a physician and medical assistant concerning a 17 year old female who on 13-MAR-2008 was vaccinated into right arm with her third dose GARDASIL (lot# 659653/1448U). On 17-Mar-2008, in the morning (4 days post vacciantion), the patient developed a fever of 100F, congestion, coughing. The dates and lot numbers of the first two doses were not provided. Unspecified medical attention was sought by calling office. The patient was advised to take ADVIL for fever and ROBITUSSIN for cough and call office if no improvement within 24 hours. It was reported that the patient's mother had reported that on 18-MAR-2008 (next day) the patient recovered from her experiences. No other information available. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Vaccination complication
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on unspecified date was vaccinated intramuscularly with 0.5 ml dose of Gardasil (lot# unspecified).  It was reported that on unspecified date, a week after the vaccination the patient developed a rash from head to toe.  The patient had a full work up with an allergist and physician.  On unspecified date the patient recovered from her experience.  It was determined that the rash was caused by Gardasil.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received form a health professional concerning a female who was vaccinated on an unspecified date with GARDASIL. Subsequently the patient experienced extreme swelling and redness at the injection site. It was reported that the site "looked infected." Subsequently, the patient recovered from extreme swelling and redness at the injection site. The patient sought unspecified medical attention.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated IM with the first dose of Gardasil (lot# not reported). Per the reporter the patient experienced a rash on her trunk 2 days after the first dose. The patient sought unspecified medical attention. The nurse did not have the patient's chart and could not find her chart during the phone call. No other information was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Biopsy skin abnormal, Drug eruption, Keratosis pilaris, Rash papular, Rash pustular
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who in June 2007, was vaccinated with the first dose of Gardasil (lot # 657617/0384U). In December 2007, the patient was vaccinated with the third dose of Gardasil (lot # 659437/1266U). Subsequently the patient experienced rash. The reporting nurse was from the dermatologist office who reported the patient had a rash from the GARDASIL. The rash was on both arms of the patient, the triceps, and back. The office did not administer the vaccine, it was given at a different office. The patient sought unspecified medical treatment by speaking to the physician. A biopsy of the rash showed it was viral and a drug related eruption. The patient reports this is the only medication she has had since the rash. The patient received all three doses, however information pertaining to the second dose is missing. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a health professional concerning a 16 year old female with tiny red bumps with keratosis pilaris on the triceps and a mother with malignant melanoma, who on 15-JUN-2007 at 10:50 was vaccinated with the first dose of GARDASIL (lot # 657617/0384U). Subsequently, the patient developed a rash on both of her legs. On 15-AUG-2007 at 11:05 the patient was vaccinated with a second dose of GARDASIL. Concomitant vaccination included BOOSTRIX. On 18-DEC-2007 at 09:35, the patient was vaccinated with the third dose of GARDASIL (lot # 659437/1266U). Subsequently the patient experienced rash on her trunk. The reporting nurse was from the dermatologist office who reported the patient had a rash from the GARDASIL. The office did not administered the vaccine, it was given at a different office. The patient sought unspecified medical treatment by speaking to the physician. On 15-JAN-2008 the patient was seen in the physician's office. The patient had 3 tiny papules on her upper lateral thighs, with 2 on the right and one on the left. The patient had a few tiny papules and pustules on her upper back and a few infected comedones on her face. The physician reported that she did not believe the reaction was related to the vaccination at all. It was reported that the tiny spots on her legs looked like irritated hair follicles from shaving. The patient was advised to stop shaving for a few weeks to she if the symptoms would resolve. The rash on the patient's upper back was diagnosed as very mild inflammatory acne. The patient was treated with EXODERM 2%, and was referred to a dermatologist. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Viral test positive
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who in June 2007, was vaccinated with the first dose of Gardasil (lot # 657617/0384U). In December 2007, the patient was vaccinated with the third dose of Gardasil (lot # 659437/1266U). Subsequently the patient experienced rash. The reporting nurse was from the dermatologist office who reported the patient had a rash from the GARDASIL. The rash was on both arms of the patient, the triceps, and back. The office did not administer the vaccine, it was given at a different office. The patient sought unspecified medical treatment by speaking to the physician. A biopsy of the rash showed it was viral and a drug related eruption. The patient reports this is the only medication she has had since the rash. The patient received all three doses, however information pertaining to the second dose is missing. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Initial and follow-up information has been received from a health professional concerning a 16 year old female with tiny red bumps with keratosis pilaris on the triceps and a mother with malignant melanoma, who on 15-JUN-2007 at 10:50 was vaccinated with the first dose of GARDASIL (lot # 657617/0384U). Subsequently, the patient developed a rash on both of her legs. On 15-AUG-2007 at 11:05 the patient was vaccinated with a second dose of GARDASIL. Concomitant vaccination included BOOSTRIX. On 18-DEC-2007 at 09:35, the patient was vaccinated with the third dose of GARDASIL (lot # 659437/1266U). Subsequently the patient experienced rash on her trunk. The reporting nurse was from the dermatologist office who reported the patient had a rash from the GARDASIL. The office did not administered the vaccine, it was given at a different office. The patient sought unspecified medical treatment by speaking to the physician. On 15-JAN-2008 the patient was seen in the physician's office. The patient had 3 tiny papules on her upper lateral thighs, with 2 on the right and one on the left. The patient had a few tiny papules and pustules on her upper back and a few infected comedones on her face. The physician reported that she did not believe the reaction was related to the vaccination at all. It was reported that the tiny spots on her legs looked like irritated hair follicles from shaving. The patient was advised to stop shaving for a few weeks to she if the symptoms would resolve. The rash on the patient's upper back was diagnosed as very mild inflammatory acne. The patient was treated with EXODERM 2%, and was referred to a dermatologist. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.