chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Genital pain, Genital tract inflammation, Vulvovaginal discomfort
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 09-APR-2008 was vaccinated with her first dose of GARDASIL (Lot #, route and site were not reported).  Concomitant therapy included ALESSE.  On 30-APR-2008 the patient experienced redness, soreness and swelling of the labia.  The patient sought unspecified medical attention with an office visit.  At the time of this report, the patient was recovering from redness, soreness and swelling of the labia.  No additional information was provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.  Initial and follow-up information has been received from a physician concerning a 17 year old female who on 09-APR-2008 was vaccinated with her first dose of GARDASIL (Lot #, route and site were not reported).  Concomitant therapy included ALESSE.  On 30-APR-2008 the patient experienced redness, soreness and swelling of the labia, later reported as pain and burning in the vaginal area.  Patient's vaginal culture was negative.  The patient sought unspecified medical attention with an office visit.  At the time of this report, the patient was recovering from redness, soreness and swelling of the labia.  No additional information was provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tooth avulsion
Clinical narrative: Information has been received from a physician assistant concerning a female patient (age unknown), who, on unspecified date, was vaccinated with dose of GARDASIL.  Subsequently, the patient fainted and her tooth fell out.  The patient sought unspecified medical attention.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Presyncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on unspecified dates was vaccinated with the first and second dose GARDASIL. On 20-MAY-2008, the patient received the third dose of GARDASIL. Following the immunizations the patient complained of feeling light-headed and dizzy; she didn't actually pass out, but looked like she would pass out. They laid her back on the table and it resolved without any serious sequelae. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who was vaccinated with a dose of GARDASIL (lot# not provided). Subsequently the patient experienced arm discomfort after receiving the vaccination, related to the vaccine feeling cold. Unknown medical attention was sought in the physician's office. The patient's outcome is unknown. No product quality complaint was involved. This is one of two case from the same source (WAES# 0805USA06180). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who in approximately 2007 was vaccinated IM with the first dose of GARDASIL (lot# not provided). The patient completed series of 3 doses of GARDASIL was experiencing discomfort on both arms. The patient had started GARDASIL vaccination one year ago. The patient's both arms are achy when she either lays or leans on them. She has had pain since the completion of the series. Unknown medical attention was sought by calling the physician's office. At the time of reporting the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician and office manager concerning a female who was vaccinated on an unspecified date with an unknown # of doses of GARDASIL (lot#'s not reported).  Subsequently the patient developed HPV.  The patient sought unspecified medical attention on an unspecified date and her outcome was not reported.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning females who were vaccinated with a dose GARDASIL (lot#'s not reported). Subsequently about 20% of the patients experienced pain after vaccination and returned late for their next dose. It was also mentioned that one patient complained her arm hurt the next day. The nurse did not have any specific patient information and would not estimate the total number of patients. Attempts are being made to obtain additional identifying information to distinguish the individual patients in this report. Additional information will be provided if available. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 6/13/2008. Additional information was received. The nurse called to say that she did not have any idea how many patients experienced pain after vaccination or returned late for their next dose. She said that there was not one patient in particular who complained her arm hurt the next day. The nurse knows that these symptoms are possible side effects of the vaccination and that is what she tells the patients. No further information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Diagnostic procedure
Clinical narrative: Information has been received from a physician concerning a 21 year old female with rhabdomyosarcoma who was on an unspecified date was vaccinated with a second dose of GARDASIL.  Subsequently a couple of days after vaccination with GARDASIL the patient developed mild bruising on both her thighs.  Medical attention was sought at the office.  At the time of the report the patient was recovering.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Hypersensitivity, Pruritus generalised
Clinical narrative: Information has been received from an allergist via a physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with GARDASIL. Subsequently after the vaccination, the patient experienced itching all over the body and "other allergic reactions". No other information regarding the patient and events were known at the time. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 23 year old female who on approximately 01-MAR-2008 was vaccinated intramuscularly with her first dose GARDASIL (lot# not reported). The patient received the second dose of GARDASIL (lot# not reported) on an unspecified date. Subsequently the patient experienced a fever and rash on the vaccinated arm after receiving the first and second doses of GARDASIL. The patient sought medical attention on an unspecified date by calling the office. Subsequently, it was reported that the patient recovered from the fever and rash on her arm on an unspecified date. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 16 year old white female who on 15-NOV-2007 was vaccinated in the right deltoid with her first dose of GARDASIL (lot# 655154/1210U). There was no concomitant medication. On 16-NOV-2007 the patient suffered a severe headache and fever greater than 100F. Subsequently, the patient recovered from the severe headache and fever. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Myalgia, No reaction on previous exposure to drug, Pain, Rheumatoid factor positive
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the first and second dose of GARDASIL on unspecified dates. It was reported that there was no problem after either dose. On approximately 21-MAR-2008, the patient was given the third dose of GARDASIL. Four weeks following the third dose, approximately 21-APR-2008, the patient complained of aches, pains, and muscle soreness. The patient sought unspecified medical attention and underwent diagnostic laboratory tests eight weeks after the third dose of GARDASIL, approximately 21-MAY-2008. "ANE" and serum rheumatoid factor test were positive. No treatment or outcome information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Rash, Urticaria
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with the first dose of GARDASIL (lot# Reported as"152X"). Per the nurse, the patient developed a "systemic rash with hives on her face" a week after receiving the first dose of GARDASIL. The patient sought unspecified medical attention by contacting the physician. No further information was provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with a history of penicillin allergy and drug hypersensitivity who in August 2007, was vaccinated with the first dose and on 24-OCT-2007 was vaccinated with the second dose of GARDASIL (lot #'s not reported). On 22-MAY-2008 the patient was vaccinated with the third dose of GARDASIL (lot# not reported). Subsequently the patient experienced inappropriate schedule of vaccine administered. Concomitant therapy included hormonal contraceptives (unspecified). The patient also told the nurse that when receiving the previous injections, she experienced a moment of pain st the injection site. Some residual pain was present the next day. The patient's injection site discomfort resolved. Then sought unspecified medical attention in the physician's office. No additional information is available at this time. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TTOX, VARCEL
Symptoms: Blood glucose, Dizziness, Neurological examination
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 08-MAY-2008 was vaccinated with her first dose of GARDASIL (lot # unspecified). Concomitant suspect therapy included VARIVAX (lot # unspecified). Other concomitant therapy included MENACTRA and TETANUS TOXOIDS (lot#s unspecified). It was reported by physician, that the patient got really dizzy post vaccination on 08-May-2008. Physician noted that the patient came back on 12-May-2008 and still experiencing some dizziness, but has normal muscle strength. On unspecified date the neuro and glucose check were performed (results not reported). Unspecified medical attention was sought by visiting doctor's office. At the time of this report, the patient had not recovered. Per physician, the patient will not be receiving any further GARDASIL shots. No further information provided. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix
Clinical narrative: Information has been received from a physician concerning a 21 year old female who in 2006 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (lot # unspecified).  On unspecified dates the patient was vaccinated intramuscularly with her second and third 0.5 ml doses of GARDASIL (lot # s unspecified).  It was reported that on unspecified date after receiving all 3 doses, the patient developed "A-typical HPV cells".  On unspecified date a PAP test was performed (no results reported).  Unspecified medical attention was sought.  At the time of this report the patient had not recovered.  No additional information was given.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 26 year old female, with no pertinent medical history and no known drug reactions/allergies, who on 08-MAY-2008 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (Lot # 0152X).  There was no concomitant medication.  About one week later, approximately 15-MAY-2008, the patient developed an itchy rash and hives all over her body.  The patient was treated with steroids (unspecified) and the symptoms have since resolved on an unknown date.  The patient sought unspecified medical attention.  No product quality complaint was involved.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female, with unknown medical history, who on 21-MAY-2008 was vaccinated with (route unknown) with a third dose of GARDASIL (Lot# unknown). On 21-MAY-2008 the patient contacted the nurse practitioner complaining of a severe headache. The nurse practitioner reported that the patient told her that she took ADVIL and is feeling much better. No product quality
Sex: U
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician who heard from another physician in another city, concerning a patient vaccinated with a dose of GARDASIL (route, site, dose# and Lot# not provided). Subsequently the patient experienced anaphylactic reaction. The patient sought unknown medical attention. The patient's outcome is unknown. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a 64 inch, 92 pound, 24 year old, generally healthy, female, witness advocate, who on an unspecified date was vaccinated with the first dose of GARDASIL, in the left deltoid.  On 07-APR-2008 the patient was vaccinated with her second dose of GARDASIL, in the left deltoid, lot # 659965/1978U.  On 09-MAY-2008, the patient sought medical attention for a "sick visit", she complained of a bump in the left deltoid area at the site of the injection.  It was reported that the patients arm was very thin and the first and second shot were done in the deltoid of the left arm.  A magnetic resonance image was taken on an unspecified date and showed possible infective etiology.  The patient was treated with unspecified antibiotics.  At the time of reporting, the patient was still being treated.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site irritation, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a Registered Nurse concerning a 17 year old female who on 21-MAY-2008 was vaccinated "subcutaneously below the deltoid but above the elbow (arm unspecified)" with a first dose of GARDASIL (lot # 0152X). There was no concomitant medication. It was reported that "the patient was walking out of the clinic and the nurse noticed the patient had a large knot at the injection site in which there was redness, swelling, and irritation. The patient had this reaction within 15 minutes of receiving GARDASIL. The patient was given TYLENOL and warm heat. The nurse spoke to the patient this morning and the redness was getting better." Patient outcome was reported as recovering. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Dizziness, Fatigue
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 21-MAY-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL. On 22-MAY-2008 the patient fainted at school after receiving her first dose the day before. It was reported the patient did not have breakfast or anything to drink before lunch and was sent home from school. The mother of the patient reported the patient continued to have symptoms of weakness, back pain, fever, fatigue, dizziness and vomited during the night. The patient required an office visit. The patient's outcome was reported as not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/13/2008.  The patient never came back to the office therefore the physician has no additional information about the patient. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 21-MAY-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL. On 22-MAY-2008 the patient fainted at school after receiving her first dose the day before. It was reported the patient did not have breakfast or anything to drink before lunch and was sent home from school. The mother of the patient reported the patient continued to have symptoms of weakness, back pain, fever, fatigue, dizziness and vomited during the night. The patient required an office visit. The patient's outcome was reported as not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/13/2008.  The patient never came back to the office therefore the physician has no additional information about the patient. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pharyngeal oedema, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 17-APR-2008 was vaccinated with the first dose of GARDASIL (lot # 0151X), 0.5ml, IM.  Concomitant therapy included LO/OVRAL.  The nurse reported that the patient received the first dose of GARDASIL, and experienced lightheadedness, dizziness and hives on the day that she received the vaccine.  The patient received the vaccine early in the morning and experienced the symptoms later that day while at school.  She went to the school nurse and while she was at the nurses' office she began to experience swelling of her throat.  An ambulance was called and the patient was taken to the emergency room where she was given intravenous BENADRYL.  The patient's symptoms improved after receiving the BENADRYL.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nervousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (Dose #, lot #, site and route were not reported).  The patient was "shaking a little and then collapsed" after receiving the vaccine.  The patient sought unspecified medical attention by calling the office.  No additional information was provided.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abnormal, Drug exposure during pregnancy, Ovarian cyst, Pregnancy test positive
Clinical narrative: Information has been received from a registered nurse for the Pregnancy Registry for concerning a 15 year old female with no medical history and no drug reactions/allergies, who on 01-Oct-2007, 03-Oct-2007 and 08-Apr-2008 was vaccinated intramuscularly with first, second and third doses, respectively, of 0.5ml of GARDASIL (lot #'s: 658560/1062U, 658563/1063U, 659439/1267U) and became pregnant. Concomitant therapy on 01-Oct-2007, included MENACTRA. On 08-APR-2008 the patient was diagnosed with ovarian cyst. The patient sought unspecified medical attention with another physician. On unspecified date abdominal CT scan for ovarian cyst was performed (results not reported). On unspecified date the patient took urine pregnancy test that positive (LMP=18-Mar-2008). Outcome unknown. No further information available. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site pain, Local reaction
Clinical narrative: Information has been received from a nurse practitioner concerning an other nurse's daughter, who on unspecified date was vaccinated subcutaneously with her first dose of GARDASIL (lot# unspecified).  Subsequently the patient experienced local injection site reaction with "achiness".  Unspecified medical attention was sought.  At the time of this report the patient's outcome was unknown.  No other information provided.  Additional information has been requested. This is in follow-up to reports previously submitted 6/11/2008. Initial and follow-up information has been received from a nurse practitioner concerning an other nurse's (23 year old daughter, who on 21-MAY-2008 at 4:00pm was vaccinated subcutaneously with her first dose of GARDASIL (lot# 659964/1976U). Subsequently the atient experienced local injection site reaction with "achiness". Unspecified medical attention was sought. At the time of this report the patient's outcome was unknown. No other information provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with asthma and allergy to amoxicillin, who on 22-MAY-2008 was vaccinated intramuscularly with her second 0.5ml dose of GARDASIL (lot # 659964/1978U). Shortly after being vaccinated, the patient developed tingling in her arm, swelling and redness at the injection site, low fever (101.8 F), chills, shakiness, nausea and dizziness. It was reported that the patient was seen the next day in office and the symptoms seemed to be improving. At the time of this report, the patient was still recovering. No other information was available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Pyrexia, Tremor
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with asthma and allergy to amoxicillin, who on 22-MAY-2008 was vaccinated intramuscularly with her second 0.5ml dose of GARDASIL (lot # 659964/1978U). Shortly after being vaccinated, the patient developed tingling in her arm, swelling and redness at the injection site, low fever (101.8 F), chills, shakiness, nausea and dizziness. It was reported that the patient was seen the next day in office and the symptoms seemed to be improving. At the time of this report, the patient was still recovering. No other information was available. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 20 year old female (twin sister), who in approximately March 2008 (date reported as "within the last two months) was vaccinated with GARDASIL (lot# unspecified).  It was reported that on unspecified date after receiving GARDASIL the patient and her twin sister developed Shingles.  It was also reported that "they do not live together".  Unspecified medical attention was sought.  At the time of this report, the outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning an approximately 23 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (lot # not reported). Subsequently the patient developed hives and a rash. It was reported that "the adverse experience lasted a couple days". On an unspecified date the patient recovered. The physician has decided to discontinue the series. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.  Initial and follow up information has been received from a physician concerning an approximately 23 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot # site and route not reported).  Subsequently the patient developed hives and a rash.  It was reported that "the adverse experience lasted a couple days".  On an unspecified date the patient recovered.  The physician has decided to discontinue the series.  The doctor "feels that it was unrelated" to GARDASIL, that it was a "pre-existing viral condition".  No additional information was provided.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, Laboratory test, Pain
Clinical narrative: Information has been received from a registered nurse concerning a female (age unreported), with no specified medical history or drug allergies, who on unspecified dates was vaccinated with the first and second dose of GARDASIL.  On 14-MAY-2008, the patient received her third dose of GARDASIL, (lot # not reported).  On 15-MAY-2008, the patient developed a temperature of 101 degrees Fahrenheit, a headache, and body aches.  The patient went to the emergency room on an unspecified date and her temperature reached 104 degrees Fahrenheit.  On an unreported date, she had laboratory tests to check for meningitis, no results were provided.  No treatment information has been provided.  At the time of this report the patient was recovering.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inflammation
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL.  She reported that the patient developed a delayed inflammatory response that started 3 days after vaccination.  She did not want to provide any further information about the patient or the delayed inflammatory response.  The patient's outcome was unknown.  Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning her 11 year old daughter with no pertinent medical history who on 28-MAR-2008 was vaccinated with a first dose GARDASIL (Lot # 658556/1060U). There were no concomitant medications. On 28-MAr-2008, several hours after vaccination she developed  a rash. The rash covered her body except her face and neck. The patient required an office visit and was treated with BEABDRYL. The rash resolved in 3 to 4 days. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 20-MAY-2008 was vaccinated with a third dose of GARDASIL.  On 20-MAY-2008, after vaccination the patient "passed out."  The patient sought unspecified medical attention.  The patient outcome was unknown.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Information has been received from a physician concerning a 23 year old female who was "very nervous and anxious upon receiving" the first dose of GARDASIL (lot # not reported). The physician reported that he administered the first dose of GARDASIL to the patient who fainted after receiving the vaccine. The patient was given some juice and sat in a chair for 15 minutes after the first episode and then fainted again. She fell to the floor and hit her head. She did not have to go to the hospital, but the doctor reported that he felt there might be some underlying cardiac issue. The patient was referred to a cardiologist. The physician did not feel this was directly caused by GARDASIL because the patient shared that she had this same experience when receiving other vaccines. Patient outcome was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a nurse concerning a female (age unknown) with warts on feet, who was vaccinated (route unknown) on an unspecified date with her first dose of GARDASIL (lot# not reported).  The nurse reported that the patient had three large warts on her foot that cleared up 4-5 days after she received the vaccination.  Unspecified medical attention was not sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 19 year old female with asthma who on 22-MAY-2008 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (Lot # 660387/1967U).  Concomitant therapy included SINGULAIR.  On 27-MAY-2008 the patient experienced tenderness, redness, pain in the arm, swelling in the left arm, mild erythema covering approximately 5-6 cm,  at the injection site, heat at the injection site and discomfort.  On 28-MAY-2008, it was reported that "the reactions are worse today".  The physician recommended that the patient take TYLENOL or MOTRIN. The patient sought medical attention in the doctor's office. The physician prescribed DURICEP and ibuprofen (unspecified). On an unspecified date, the patient recovered. No additional information is available. Additional information has been requested.  Additional infromation is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 19 year old female with asthma who on 22-MAY-2008 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (Lot # 660387/1967U).  Concomitant therapy included SINGULAIR.  On 27-MAY-2008 the patient experienced tenderness, redness, pain in the arm, swelling in the left arm, mild erythema covering approximately 5-6 cm,  at the injection site, heat at the injection site and discomfort.  On 28-MAY-2008, it was reported that "the reactions are worse today".  The physician recommended that the patient take TYLENOL or MOTRIN. The patient sought medical attention in the doctor's office. The physician prescribed DURICEP and ibuprofen (unspecified). On an unspecified date, the patient recovered. No additional information is available. Additional information has been requested.  Additional infromation is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Wrong drug administered
Clinical narrative: Information has been received from a nurse midwife for the Pregnancy Registry for GARDASIL concerning a 26 year old female with an allergy to morphine, who on 12-MAY-2008 was vaccinated intradermally with GARDASIL (lot# not reported) while pregnant.  There was no concomitant medication.  It was reported that the patient received GARDASIL when the patient was 7 weeks 3 days pregnant (LMP = 21-Mar-2008) and the estimated date of delivery was 27-Dec-2008.  The patient was to get a tuberculosis skin test and in error received GARDASIL intradermally.  No product confusion was discovered, but the nurse midwife was not sure how the error was made.  On 12-May-2008 after vaccination, the patient developed a local reaction at the injection site, described as itchy, raised and red 2 cm in diameter.  Unspecified medical attention was sought during an office visit.  At the time of this report, the patient's local reaction at the injection site, persisted.  No other information available.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Contraception, Pruritus, Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female who on 27-FEB-2008 was vaccinated IM in the left deltoid with a first 0.5 ml dose of GARDASIL (Lot #660387/1967U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 28-FEB-2008 the patient experienced pruritus and developed urticaria and was treated with BENADRYL.  Subsequently, the patient recovered.  On 23-APR-2008 she was vaccinated with a second dose of GARDASIL (Lot #660387/1967U) and on 28-APR-2008 experienced pruritus and developed urticaria and was treated with BENADRYL.  The patient sought medical attention via telephone.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Drug administered at inappropriate site, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 13 year old female who on 05-Jan-2008 was vaccinated IM with a first dose GARDASIL (Lot #6553271/1287U) "in the glute." Shortly after vaccination the patient experienced arm pain, joint pain, and chest wall pain. On 01-MAR-2008 she was vaccinated IM with a second dose of GARDASIL in the deltoid. The patient did not inform the physician of the adverse events associated with the 1st dose until after the administration of the 2nd dose. The "pain was still there from the 1st dose when the 2nd dose was given." The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: HPV4
Symptoms: Flushing, Inappropriate schedule of drug administration, Incorrect route of drug administration, Malaise, Tachycardia
Clinical narrative: Information has been received from a 31 year old male physician who on an unspecified date in March 2008, was vaccinated with his first dose of GARDASIL (Lot #, site and route not reported).  On 28-MAY-2008 the patient was vaccinated subcutaneously in the right arm using an 18 gauge needle with his second dose of GARDASIL (Lot #, site and route not reported).  The physician stated that he felt a little flushed, malaise, and a little tachycardic post vaccination, "but feels fine now".  On 28-MAY-2008, the patient recovered from being a little flushed, malaise and a little tachycardic.  The patient sought unspecified medical attention.  No additional information was provided.  No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown) who was vaccinated (route unknown) into the hip area with a dose of GARDASIL (Lot # unknown).  Subsequently, on an unknown date the patient experienced numbness in the leg.  It was reported that the patient is fine, numbness has resolved, no other issues.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: Information has been received from a physician concerning her 17 year old niece who on approximately 15-MAY-2008 was vaccinated with the second dose of GARDASIL (lot number not reported). Subsequently the patient underwent a pap smear between the first and second dose that showed stage 1 cervical dysplasia. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Limb discomfort
Clinical narrative: Information has been received from a healthcare worker concerning a female patient who was vaccinated with a dose of GARDASIL (lot# not provided).  Subsequently the patient experienced arm discomfort after receiving the vaccination, related to the vaccine feeling cold.  Unknown medical attention was sought in the physician's office.  The patient's outcome is unknown.  No product quality complaint was involved.  This is one of two cases from the same source (WAES# 0805USA04694).  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL (lot not reported). On 22-mAY-2008, 48 hours post vaccination the patient went to the E.R. experiencing shingles rash on her neck. The patient was given unspecified pain medication and discharged from the E.R. The patient's outcome was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain, Sensation of heaviness
Clinical narrative: Initial and follow up information has been received from a nurse and an office worker concerning "almost all" patients (number of patients unspecified) who were vaccinated with GARDASIL (lot# not reported). The patients have been complaining of "heaviness" in the entire arm and "extreme pain" at the injection site after vaccination. It was reported that the pain occurs with all three doses. Patient outcomes were not reported. Patients reportedly sought unspecified medical attention by contacting the office. Subsequently, the patient recovered from "heaviness" in the entire arm and "extreme pain" at the injection site (not further specified). Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a Hair Dresser concerning an approximately 14 or 15 year old female customer who was "recently" vaccinated with GARDASIL. The Hair dresser reported that she tried to dye the patient's hair blond, she noticed the color bubbled and got hot and started turning blond very quickly and she had to wash it off immediately. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 21 year old female with penicillin allergy who on 29-MAY-2008 was vaccinated with a first dose of 0.5 ml GARDASIL via a subcutaneous route. There were no concomitant medications. On 29-MAY-2008, after receiving her first dose she felt lightheaded, the injection site became red and swollen, pain radiated down to her pinky and she felt "tingles" on the left side of her face. She sought unspecified medical attention from the nurse. At the time of the report the patient was recovering. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 21 year old female with penicillin allergy who on 29-MAY-2008 was vaccinated with a first dose of 0.5 ml GARDASIL via a subcutaneous route. There were no concomitant medications. On 29-MAY-2008, after receiving her first dose she felt lightheaded, the injection site became red and swollen, pain radiated down to her pinky and she felt "tingles" on the left side of her face. She sought unspecified medical attention from the nurse. At the time of the report the patient was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a 16 year old female who on 15-MAY-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 660387/19687U). There was no concomitant medication. On 16-MAY-2008 the patient developed widespread hives. The patient's mother sought medical attention on 27-MAY-2008 and the doctor recommended BENADRYL. The patient's outcome was not reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who sometime in 2007 was vaccinated intramuscularly with a first dose of GARDASIL (Lot # unknown). There was no concomitant medication. The physician reported that the patient on unknown dates experienced burning sensation after all three doses. Subsequently, on unknown dates the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/13/2008.  Follow up information has been received from a 36 year old female physician with no pertinent medical history, who on 18-JUL-2007 at 10:15 AM was vaccinated with the first dose of GARDASIL IM, on 29-AUG-2007 at 11:00 AM was vaccinated with the second dose of GARDASIL (Lot # 9725101) IM on 21-FEB-2008 at 11:00 AM. On 18-JUL-2007 at 10:15 AM, the patient experienced painful administration sensation of ardor on muscular area that persisted for almost 3-5 minutes. The patient experienced the symptoms with all three vaccine administration. There was no illness at the time of vaccination. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 32 year old female who in 2007 was vaccinated on unspecified dates with all three doses of GARDASIL (lot#'s not reported). There was no concomitant medication. On 19-MAY-2008 the patient had a pap test which showed she was at high risk for HPV. Prior to this her PAP tests were negative. The patient's high risk for HPV persisted and the patient sought medical attention by calling the office on an unspecified date. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a female patient who in November 2007, was vaccinated with a first dose of GARDASIL (lot # not provided). Concomitant therapy included other unspecified vaccines administered on the same day. Post vaccination, the patient experienced hair loss. Subsequently, the patient recovered from the hair loss. The patient sought medical attention at the office. The patient refused to get the second dose. No product quality complaint was involved. Additional information has been requested.  10/08/08 This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow up information has been received from a physician concerning a 13 year old female patient, with no medical history, no known drug allergies, no adverse events following prior vaccination and no illness at time of vaccination, who on 11-Aug-2007 (first reported as November 2007 and then as 01-Aug-2007), was vaccinated with a first IM dose of GARDASIL (lot # 655205/1426F). There were no other vaccines administered on this same day (previously reported that concomitant therapy included other unspecified vaccines administered on the same day). On 14-May-2008, the patient returned for her annual check-up and the doctor inquired about why the patient had not returned for her second vaccination. At that time, the patient's mother reported that the patient had experienced hair loss after receiving the first dose (followup information reported the onset date of 11-Oct-2007, 2 months after receiving the first dose). The hair loss lasted for two months (followup information reported duration of 10 to 12 weeks) and then she recovered all hair (followup information also reported date of recovery as May 2008). The patient sought medical attention at the office. The patient refused to get the second dose. No other information is expected.
Age: 51.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: Information has been received from a 51 year old male consumer with a history of drug reaction to CEFZIL, who on 28-MAY-2008 was vaccinated with his first dose of GARDASIL (Lot #, site and route not reported).  The patient received his first dose of the vaccine "as prescribed by his physician because he was told by his girlfriend that she has 1 strain of HPV that can cause cervical cancer".  On 28-MAY-2008, "right after receiving the first dose" he experienced "sore in the injection site".  The patient sought unspecified medical attention.  On an unspecified date, the patient recovered from "sore in the injection site after receiving first dose".  No additional information was provided.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: This is in follow-up to report(s) previously submitted on 6/13/2008. Initial and follow up information has been received from a physician concerning a 17 year old female (154 lb; 68 in), with no reported medical history and no known drug allergies, who on 28-MAY-2008 (previously reported as 27-MAY-2008) was vaccinated intramuscularly (previously reported as SQ) in the left arm with her third dose of GARDASIL (Lot # 660387/1967U). On 28-MAY-2008 (also reported as 27-MAY-2008), approximately 1 minute after the vaccine was administered the patient fell out of the chair and lost consciousness for about 20 seconds. She hit her parietal area of the head against the table when she fell and sustained a "bump on the head" (also reported as "had a goose egg"). She recovered immediately and was given crackers and coke. The reporting physician considered the events to be non-serious. The dates, lot #s, route and sites of administration of the first two doses of GARDASIL were not known. The patient sought unspecified medical attention in the office. No additional information was available. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 25 year old female with a seizure disorder and a history of depression, anxiety and migraines who on 30-MAY-2008 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot # 660389/1968U).  Concomitant therapy included LAMICTAL, DEPAKOTE and TOPAMAX.  On 30-MAY-2008, 30 seconds after receiving the vaccination, the patient fainted on the table.  The patient was monitored and received unspecified treatment in the office.  It was reported that the patient was recovering from the fainting.  No additional information was available.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Malaise, Nausea, Pyrexia
Clinical narrative: Information has been received from a 22 year old female with sulfonamide allergy to an unspecified pertussis vaccine and a history of kidney stone and other kidney problems who in January 2008, was vaccinated with the first dose of GARDASIL (lot#, dose and route not reported).  Concomitant therapy included YAZ and ZOLOFT.  In January 2008, after first dose of GARDASIL the patient reported that the injection site was very swollen and painful for approximately 4 weeks.  She noted that after the second dose of GARDASIL (lot #, date, dose and route not reported) the injection site became swollen and painful.  The patient also noted that 5-6 hours after vaccination she developed a fever, began vomiting, and proceeded to feel nauseous and sick for approximately 3 weeks.  At the time of the report, the patient reported that she no longer felt sick; however the injection site was still swollen and painful.  Unspecified medical attention was sought.  No further information was available.  Additional information is not expected.