chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Skin lesion
Clinical narrative: Information has been received from a health professional concerning an 18 year old female with a history of recurrent rash after the second dose of GARDASIL who on approximately 17-MAR-2008 was vaccinated intramuscularly with her third dose of GARDASIL (lot# not reported). There was no concomitant medication. On 31-MAR-2008 the patient experienced a red rash on her feet, right thigh and elbows. The rash was made up of clusters of reddish circular lesions, about 1cm in diameter. The centers of the lesions were more purple in color than the borders. The patient was treated with Prednisone and ALLEGRA and was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a female patient who reported her friend who on an unspecified date was vaccinated at another physicians office with a dose of GARDASIL (lot #unknown, site and route not reported). There was no concomitant medication. The patient had reported that her friend had "experienced lightheadedness while" driving 2.5 hours after receiving the vaccination. No additional information was reported. The patient's outcome was not reported. No further information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 12 year old female who on 24-JAN-2008 was vaccinated IM with the first dose of GARDASIL. On 28-MAR-2008, the patient was vaccinated IM with the second dose of GARDASIL. The patient reported pain in the arm at the injection site for 3 days after the vaccination was given. The pain in the arm included not being able to lift the arm. The nurse also reported that since multiple patients (3 patients) reported pain in their arms, they started giving the vaccination in the buttocks to an unspecified number of patients. Unknown medical attention was sought through contact with the nurse. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES # 0804USA05546 and 0805USA01522). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who on 18-OCT-2007 was vaccinated IM with the first dose of GARDASIL.  On 30-OCT-2007, the patient was vaccinated IM with the second dose of GARDASIL and on 14-MAR-2008, the patient was vaccinated IM with the third dose of GARDASIL.  The patient reported pain in the arm at the injection site for 3 days after the vaccination was given.  The pain in the arm included not being able to lift the arm.  The nurse also reported that since multiple patients (3 patients) reported pain in their arms, they started giving the vaccination in the buttocks to an unspecified number of patients.  Unknown medical attention was sought through contact with the nurse.  Patient outcome was unknown.  No product quality complaint was involved.  This is one of the multiple cases from the same source (WAES # 0804USA05546 and 0805USA01521).  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Sneezing
Clinical narrative: Information has been received from a company representative, as told by the patient's mother, concerning an 11 year old female who on 15-MAR-2008 was vaccinated with her third dose of GARDASIL (lot# not reported). There was no concomitant medication. On 15-MAR-2008 the patient started sneezing which lasted for 4 days. Subsequently, the patient recovered from sneezing. The mother gave the patient BENADRYL, but it did not help. The patient sought unspecified medical attention. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Headache, Syncope
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on approximately 18-MAR-2008 was vaccinated with GARDASIL (lot# not reported). Concomitant therapy included VARIVAX, for the treatment of prophylaxis (duration and dose not reported) and VAQTA, for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included MENACTRA. On approximately 18-MAR-2008 the patient fainted shortly after the vaccinations. Subsequently, the patient completely recovered from fainting before leaving the office. Additional information has been requested. 02/18/2010 Information and follow up has been received from a health professional concerning a 13 year old female with a history of congenital nystamia who on 12-MAR-2008 was vaccinated intramuscularly in the right arm with her first does of GARDASIL (lot# 659182/1757U). Concomitant therapy included the second dose of VARIVAX (duration and dose not reported) subcutaneously in the left arm (lot# 659941/1791U). Other concomitant therapy included the first dose of HAVRIX intramuscularly in the right arm (lot# AHAVB256AA) and the first dose of MENACTRA intramuscularly in the left arm (lot# U2550AA). She experienced a mild headache and was prescribed Motrin. At the time of vaccinations the patient had Otitis media.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a female who in January 2008, was vaccinated with her second dose of GARDASIL.  In January 2008, the patient experienced swelling, pain and redness at the injection site.  The patient's swelling, pain and redness at injection site persisted.  The patient sought unspecified medical attention in the office and had an MRI.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness
Clinical narrative: Information has been received from a physician concerning a 12 year old female who was recently IM vaccinated with GARDASIL (lot number 655208/1426F). Subsequently the patient felt woosie. While the patient was in office, she started to have some mild dizziness which she recovered from. However, at home, she complained of increasing dizziness and was unable to get out of bed all evening. The patient recovered on 05-Apr-2007. No other information was available.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a female who was IM vaccinated with all three doses of GARDASIL (lot numbers unspecified). Subsequently after each dose, the patient experienced a headache that lasted all day then resolved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Abdominal distension, Back pain, Cystitis, Kidney infection, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her daughter, a 20 year old female with a kidney infection and bladder infection and a history of occasional bladder infections and yeast infections who on 21-NOV-2007 was IM vaccinated with her first dose of GARDASIL (lot number unspecified).  On 04-Feb-2008 she went to the physician's office to receive the second dose of GARDASIL and was inadvertently given hepatitis B vaccine (lot number and manufacturer unspecified).  On 04-Feb-2008 the patient experienced wrong drug administered.  On 16-Mar-2008 the patient was taken to the emergency room with low back pain, vomiting and swelling in abdomen.  The patient was diagnosed with a bad kidney infection and bladder infection.  Patient was given IV antibiotics and IV for hydration and sent home with oral antibiotics.  Patient tried taking the oral antibiotics and would vomit after taking them from upset stomach.  On 19-Mar-2008 the patient went back to the Emergency room and was treated with IV antibiotics and saline IV.  On 01-Apr-2008 the patient completed the oral antibiotics and is feeling better.  Subsequently, the patient recovered from the wrong drug being administered, kidney infection, bladder infection, and vomiting.  Unspecified blood work was done at the hospital however the reporter did not know the results.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Stomach discomfort, Vomiting, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her daughter, a 20 year old female with a kidney infection and bladder infection and a history of occasional bladder infections and yeast infections who on 21-NOV-2007 was IM vaccinated with her first dose of GARDASIL (lot number unspecified).  On 04-Feb-2008 she went to the physician's office to receive the second dose of GARDASIL and was inadvertently given hepatitis B vaccine (lot number and manufacturer unspecified).  On 04-Feb-2008 the patient experienced wrong drug administered.  On 16-Mar-2008 the patient was taken to the emergency room with low back pain, vomiting and swelling in abdomen.  The patient was diagnosed with a bad kidney infection and bladder infection.  Patient was given IV antibiotics and IV for hydration and sent home with oral antibiotics.  Patient tried taking the oral antibiotics and would vomit after taking them from upset stomach.  On 19-Mar-2008 the patient went back to the Emergency room and was treated with IV antibiotics and saline IV.  On 01-Apr-2008 the patient completed the oral antibiotics and is feeling better.  Subsequently, the patient recovered from the wrong drug being administered, kidney infection, bladder infection, and vomiting.  Unspecified blood work was done at the hospital however the reporter did not know the results.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated on an unspecified date with a dose of GARDASIL (lot# not reported) and fainted. Subsequently, the patient recovered from fainting. The nurse was told about this AE from another nurse. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 5/14/2008. No additional information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 31-JUL-2007 was vaccinated with her second dose of GARDASIL (lot# not reported).  On 14-MAR-2008 the patient was vaccinated with her third dose of GARDASIL (lot# not reported).  On approximately 14-MAR-2008 the patient experienced a raised area at the injection site.  The area was the size of an egg.  The patient's raised area at the injection site persisted and was coming to the office on 02-APR-2008 for an examination.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a college-age female who on unspecified dates, was vaccinated with the first, second and third doses of GARDASIL. Subsequently the patient experienced five abnormal pap smears since receiving GARDASIL. Prior to receiving GARDASIL, the patient had normal pap smears. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested. 07/08/2008 This is in follow-up to report(s) previously submitted on 5/14/2008. Information has been received from a registered nurse concerning a college-age female between the age of 19-21, who on unspecified dates, was vaccinated with the first, second and third doses of GARDASIL. Subsequently the patient experienced five abnormal pap smears since receiving GARDASIL. Prior to receiving GARDASIL, the patient had normal pap smears. The patient sought unspecified medical attention. It was reported that the patient underwent further testing and the results were reported as negative. No product quality complaint was involved. This is one of two reports from the same source. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a patient's friend who was vaccinated with GARDASIL and developed Bell's Palsy. No specified symptoms, duration, or treatment reported. No other information was available. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2008. Information has been received from a medical assistant concerning a female in her teens with no pertinent medical history who in March 2008, was vaccinated with a first dose of GARDASIL from her OB/GYN. There was no concomitant medication. Subsequently, "soon after administration" the patient developed persistent nausea for the last 2 weeks. The patient has an appointment to see the office (her primary physician). At the time of reporting the patient had not recovered. Additional information has been requested. Follow-up information was received from a health care professional. The office did not administer the GARDASIL however the patient was presented to the office on 02-APR-2008 and stated she might have had a reaction to the GARDASIL. Her symptoms were nausea. The patient also had recently began taking a new birth control pill (unspecified). The physician had seen the patient and explained that he could not determine if the nausea was due to the vaccine. The physician felt like it was more possible that it was due to the change in her OCP. The patient was prescribed medication for nausea. At the time of reporting it was unknown if the patient had recovered. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Rash
Clinical narrative: Information has been received from a physician's assistant concerning a 20 year old female with no drug reactions/allergies and no pertinent medical history who on 11-JAN-2008 was vaccinated with GARDASIL (lot#653938/0954F) 0.5 mL IM. Concomitant therapy included hormonal contraceptives (unspecified). On approximately 12-JAN-2008 or 13-JAN-2008 the patient experienced swelling of neck with a rash and bumps on the neck, no difficulty breathing. Unspecified medical attention was sought in the office. On an unspecified date the symptoms resolved in a few days. No additional information at this time. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a health professional concerning an 11 year old white female who on 27-MAR-2008 at 14:00 was vaccinated intramuscularly into the left deltoid with the third dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included a second dose given intramuscularly into the left deltoid of HAVRIX (Lot # AHAVB256AA). On 27-MAR-2008 at 14:00 the patient experienced nausea. On 27-MAR-2008 the patient recovered. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Migraine
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on 31-JAN-2008 was vaccinated with the first dose of GRADSIL, 0.5 mL, IM. Concomitant medication was not reported. On an unspecified date in 2008, the patient had "periods of blacking out" after she received the vaccination. It was also reported that the patient was having migraine headaches. The reporting nurse practitioner stated that the neurologist felt that the symptoms were not related to GARDASIL. The patient will not complete the series of vaccinations. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site papule, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 14 year old female with depression who on 14-FEB-2008 was vaccinated with a second GARDASIL (lot# 659657/1487U) injection. Concomitant therapy included CELEXA and LOESTRIN. On 15-FEB-2008 the patient developed fever. On 16-FEB-2008 the patient developed hives. On 19-FEB-2008 the patient had swelling at the injection site about the "size of a fist". On 20-FEB-2008 the patient came into the office and only had a "pin head size papular at the injection site". All other symptoms were gone. At the time of reporting the patient had recovered. It was reported that the patient had no reaction to the first dose and the patient will not be receiving the third dose. No further information was provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a health professional concerning a 15 year old white female who on 27-MAR-2008 at 14:00 was vaccinated intramuscularly into the left deltoid with the third dose of GARDASIL (Lot # 660387/1967U). Concomitant therapy included a first dose intramuscularly given into the left deltoid on the same day at 14:00 of HAVRIX (Lot # AHAVB256AA). On 27-MAR-2008 at 14:10 the patient experienced nausea. On 27-MAR-2008 the patient recovered. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 03-DEC-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL. Subsequently the patient developed a hive like, red rash over her entire body. The patient sought unspecified medical attention. The rash lasted approximately two weeks and then resolved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a health professional (reported as a nurse or a medical assistant) concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of GARDASIL.  Subsequently, the patient passed out in the office post vaccination.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Inappropriate schedule of drug administration, Rash pruritic, Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a 33 year old female with a history of an abnormal papanicolaou smear, on 01-OCT-2007 was vaccinated with a prefilled syringe IM in the arm with a first dose of GARDASIL (Lot# 658282/0929U). It was reported that the patient insisted on getting the vaccine, despite the recommendation of the physician. On 03-DEC-2007 the patient was vaccinated with a second dose of GARDASIL (Lot# 659437/1266U). Concomitant therapies included hormonal contraceptives (unspecified) and "hormones."  About a month post vaccination, on 07-JAN-2008 the patient developed a "hive type rash." The rash was reported to be itchy and burning. The patient called the office. On 08-JAN-2008 the patient saw an allergist. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL, 0.5 mL.  Concomitant medication was not reported.  Subsequently on an unspecified date, the patient experienced a missed menstrual period after she received GARDASIL.  Unspecified medical attention was sought.  It was reported that the patient missed her menstrual period for a period of 3 months after vaccination with GARDASIL.  The outcome and causality of the event was not reported.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin discolouration
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who, on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently the patient developed skin discoloration (area of skin discoloration was not reported). The outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase, Myalgia
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who, on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently, on an unspecified date, the patient developed muscle soreness after vaccination. It was unknown which muscles were involved. The patient was seen in the office. A creatine phosphokinase test was done, results not reported. The outcome was unspecified. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Neck pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female student (weight 107lbs, height 62-75')who on 19-SEP-2007 was vaccinated with the first dose of GARDASIL (Lot #658556/1060U).  On 29-NOV-2007, the patient was vaccinated with the second dose of GARDASIL (Lot #659435/1265U).  On 02-APR-2008, the patient was vaccinated with the third dose of GARDASIL (Lot #659653/1448U).  Concomitant medication was reported as none.  On an unspecified date in December 2007 a few days after the second vaccination, the patient experienced severe neck and shoulder pain.  The pain was severe enough that the patient was examined at the emergency room, but not admitted.  On 02-APR-2008 the evening of the third vaccination, the patient developed neck and shoulder pain which was not as severe as the pain following the second vaccination.  There was no local reaction at the injection site.  Unspecified medical attention was sought as the patient contacted the physician's office.  The patient's neck pain and shoulder pain persisted.  No product quality complaint was involved.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a female certified medical assistant who was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot # not reported).  It was reported that she had pain at the injection site of her second dose of GARDASIL (lot # not reported) series.  The pain lasted a few hours and then resolved.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Headache, Injection site discomfort, Pregnancy test
Clinical narrative: Information has been received through the pregnancy registry concerning a 22 year old female patient with no known drug allergies and no medical history reported, who on 11-DEC-2007 and 01-APR-2008 was vaccinated with the first and second doses of GARDASIL respectively.  There was no concomitant medication.  The patient reported that after receiving the second dose of GARDASIL she found out she was pregnant.  She reported that her last menstrual period was from 02-FEB-2008 till around 14-FEB-2008 and that she was eight weeks and three days pregnant.  She also reported that after receiving the second dose, on approximately 01-APR-2008, of GARDASIL her head, stomach and her arm hurt at the injection site.  Unspecified medical attention was sought.  Diagnostic laboratory studies included a pregnancy test.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with an allergy to AUGMENTIN who on 18-FEB-2008 was vaccinated with the first 0.5 ml dose of GARDASIL.  There was no concomitant medication.  On 19-MAR-2008 the patient had a positive PAP smear.  Unknown medical attention was sought with the physician.  Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on an unknown date was vaccinated with the first dose of GARDASIL and 03-APR-2008 was vaccinated with the second dose of GARDASIL. The patient experienced dizziness after receiving a first dose of GARDASIL. She also experienced dizziness on 03-APR-2008 after receiving the second dose of GARDASIL as well another vaccine MENACTRA. Unknown medical attention was sought. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Back crushing, Back pain, Chest X-ray, Discomfort, Dyspnoea
Clinical narrative: Information has been received from a medical assistant concerning a 26 year old female who last week (approximately 27-March 2008), was vaccinated with the first dose of GARDASIL.  The patient developed back pains post vaccination.  The patient awoke at 2 am in the morning and felt like something was crushing her back like a "bear hug" and she could not breathe.  Medical attention was sought through a call to the medical assistant.  Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a medical assistant concerning a 25 year old female with no known drug allegies who on 27 March 2008, was vaccinated with the first dose of GARDASIL (Lot # 1757O). On 28-MAY-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 1757O). On 29-MAR-2008 the patient developed back pains post vaccination. The patient awoke at 2 am in the morning and felt like something was crushing her back like a "bear hug" and she could not breathe. It was later reported that the pateint had back discomfort/spasms which the patient determined at the time of the second injection of GARDASIL that signs of complications from the first injection might not have been caused from GARDASIL. The patient had a folt to the body several days before the first injection patient was aware of possible reaction being reported to Merck. The back discomfort lasted 1-2 days. Unspecified medical attention was sought through a call to the medical assistant. The patient had a chest x-ray. Patient outcome was recovered approximately 1-2 days after onset. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms
Clinical narrative: Information has been received from a medical assistant concerning a 26 year old female who last week (approximately 27-March 2008), was vaccinated with the first dose of GARDASIL.  The patient developed back pains post vaccination.  The patient awoke at 2 am in the morning and felt like something was crushing her back like a "bear hug" and she could not breathe.  Medical attention was sought through a call to the medical assistant.  Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a medical assistant concerning a 25 year old female with no known drug allegies who on 27 March 2008, was vaccinated with the first dose of GARDASIL (Lot # 1757O). On 28-MAY-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 1757O). On 29-MAR-2008 the patient developed back pains post vaccination. The patient awoke at 2 am in the morning and felt like something was crushing her back like a "bear hug" and she could not breathe. It was later reported that the pateint had back discomfort/spasms which the patient determined at the time of the second injection of GARDASIL that signs of complications from the first injection might not have been caused from GARDASIL. The patient had a folt to the body several days before the first injection patient was aware of possible reaction being reported to Merck. The back discomfort lasted 1-2 days. Unspecified medical attention was sought through a call to the medical assistant. The patient had a chest x-ray. Patient outcome was recovered approximately 1-2 days after onset. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Crying, Hypoaesthesia, Musculoskeletal stiffness, Respiratory rate increased
Clinical narrative: Information has been received from a nurse concerning a 24 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL and at the end of February 2008 was vaccinated IM in the arm with the second 0.5 ml dose of GARDASIL.  The patient passed out after receiving the first dose of GARDASIL.  The patient had what was described as a "high anxiety" response after receiving the second dose of GARDASIL.  The patient reported both hands and legs went numb.  The patient "stiffened up" and began breathing rapidly and crying hysterically.  No treatment besides observation and supportive methods for either episode.  Unknown medical attention was sought in the physician's office.  Patient outcome was recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Erythema, Skin warm, Swelling
Clinical narrative: Information has been received from a nurse, who was the patient's grandmother, concerning her 14 year old granddaughter who in November 2007, was vaccinated in the outer thigh with a first dose of GARDASIL. Sometime in November 2007, the patient developed swelling, redness and warmth that lasted for about a week. She was reported to have improved (date not specified). No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Information has been received from an office manager concerning a 15 year old female who on 31-MAR-2008 was vaccinated with the first dose of GARDASIL. The patient fainted and threw up after getting the first dose of GARDASIL. Unknown medical attention was sought. On an unspecified date patient was recovered. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Injection site bruising, Pain
Clinical narrative: Information has been received from a 16 year old female consumer regarding herself with a history of kidney problems when younger and no known allergies who 6 months ago was vaccinated with the first dose of GARDASIL and on 11-MAR-2008 was vaccinated with the third 0.5 ml dose of GARDASIL (no lot number provided). On 31-MAR-2008 the patient noticed a bruise at the injection site. Everytime the patient puts ice on the bruise it feels like her arm is "throbbing". There was no concomitant medication. Unknown medical attention was sought. Patient outcome was not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who was vaccinated with the third dose of GARDASIL (Lot # 658556/1060U).  The patient experienced pain at the injection site and in the arm after the third dose.  Patient outcome was unknown.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  This is one of two cases from the same source (WAES # 0804USA03130).  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Ovarian cyst
Clinical narrative: Information has been received from a health professional concerning a 16 year old female with ovarian cysts who was vaccinated with her third dose of GARDASIL (lot number unspecified). Subsequently the patient's ovarian cysts worsened and became larger. The patient sought unspecified medical treatment. The patient's ovarian cyst persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Menorrhagia, Muscle spasms
Clinical narrative: Information has been received from a health professional concerning a female who on 08-JAN-2008 was vaccinated with her first dose of GARDASIL (lot number unspecified). About two weeks after being vaccinated, on approximately 22-JAN-2008 the patient experienced heavy menstrual periods, and severe cramping which was causing her to have difficulty in walking. Patient is now visiting a specialist, but specifics unknown. The patient's heavy menstrual periods and severe cramping and difficulty walking persisted. 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 female who in February 2008, was vaccinated with the first dose of GARDASIL (lot# 660387/1967U). Per the reporter, the patient developed hives within an hour and a half of vaccination. No other symptoms were involved. The patient sought unspecified medical attention in the physician's office. Topical BENADRYL was used and the symptoms resolved the same day. No further information is available. Additional information has been requested. This is in follow-up to reportz(s) previously submitted on 5/14/2008.  No other symptoms were involved.  The patient thought unspecified medical attention in the physician's office.  BENADRYL was used and the symptoms resolved the same day.  No further information is available.  Additional information received from a Form (21-MAY-2008). The patient had no episodes of hives in the previous week other than 8 day prior while on a camping trip.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 09-JAN-2007 was vaccinated in the right arm with the first dose of GARDASIL (lot# not reported). On 09-MAR-2007 the patient was vaccinated in the left arm with the second dose of GARDASIL (lot# not reported). On 11-JUL-2007 the patient was vaccinated in the right arm with the third dose of GARDASIL (lot# not reported). Per the reporter, the patient experienced one large plantar wart on her right heel immediately following the second dose of GARDASIL. The patient was treated by a podiatrist and had the wart burned off, but 7 more warts branched out on the heel. These were treated with a combination of burning or surgical removal. The patient is still being treated by the podiatrist who feels this is related to GARDASIL. The primary care physician does not feel this is related to GARDASIL. The patient's warts have persisted. No additional information is available at this time. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature fluctuation, Feeling hot, Headache, Injection site pain, Nausea
Clinical narrative: Information has been received from a consumer, who is the mother of the patient, concerning a 14 year old female who on 02-APR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported). On 02-APR-2008 the patient experienced pain at the injection site. The mother reported that the next day the patient came home and had a bad headache, so she was given TYLENOL and was lying around the house. The consumer reported that later on that night, the patient was still complaining of the headache and that she felt nauseous, so the mother had taken the patient's temperature and it was 98.7 degrees. The mother stated that the patient was lying around the house and around 10:30 PM the patient had felt unusually warm and she had a fever of 101.3. The consumer reported that throughout the night, the patient's temperature went up and down, but she was warm all night. Per the consumer, on 04-APR-2008, the patient stayed home from school and she still feels a little warm. The consumer has not yet spoken with the physician. No further information is available and the patient has not yet recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer, who is the mother of the patient, concerning a 14 year old female who on 02-APR-2008 was vaccinated with the first dose of GARDASIL (lot# not reported). On 02-APR-2008 the patient experienced pain at the injection site. The mother reported that the next day the patient came home and had a bad headache, so she was given TYLENOL and was lying around the house. The consumer reported that later on that night, the patient was still complaining of the headache and that she felt nauseous, so the mother had taken the patient's temperature and it was 98.7 degrees. The mother stated that the patient was lying around the house and around 10:30 PM the patient had felt unusually warm and she had a fever of 101.3. The consumer reported that throughout the night, the patient's temperature went up and down, but she was warm all night. Per the consumer, on 04-APR-2008, the patient stayed home from school and she still feels a little warm. The consumer has not yet spoken with the physician. No further information is available and the patient has not yet recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Hepatic enzyme increased
Clinical narrative: Information has been received from a physician concerning a "16-17 year old" female who was vaccinated on an unspecified date with a first dose of GARDASIL (lot # not reported).  Subsequently, on an unspecified date, the patient experienced upper right quadrant pain.  The patient sought unspecified medical attention.  "She was referred to see a gastroenterologist and found out she had raised liver enzymes."  Therapy with GARDASIL was discontinued.  Subsequently, the patient recovered from upper right quadrant pain and raised liver enzymes, "after stopping therapy with GARDASIL."  No product quality complaint was involved.  Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 32 year old female physician assistant who in February 2008, reported as "a little less than 2 months ago," was vaccinated intramuscularly into the left arm with the first dose of GARDASIL.  Subsequently, she experienced pain at the injection site since being vaccinated around 2 months ago.  She also reported that she has slight swelling at the injection site or a ball that was visible at the injection site on her left arm.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who on unspecified date was vaccinated IM with all three dose of GARDASIL (lot# not provided). The patient received all three doses and later she had abnormal pap smear. Unknown medical attention was sought. The patient was not recovered. Attempts were unsuccessful to gain more information. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female who on an unspecified date was vaccinated IM with the first dose of GARDASIL.  It was reported that the patient developed a headache after being vaccinated.  Unknown medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Syncope
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter, who on an unspecified date, was vaccinated with a second dose of GARDASIL.  Subsequently, the patient didn't feel too well and fainted.  The patient was seen at the office.  At the time of the report, the outcome of the patient was unknown.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 06-JUL-2007 was vaccinated with the first dose of GARDASIL (lot# not provided).  Subsequently the patient developed a firm nodule on her arm close to the injection site about half centimeter in size.  Physician saw the nodule yesterday (03-Apr-2008) when patient visited the clinic.  It was unknown when the patient developed the firm nodule.  Medical attention was sought by visiting the physician.  The patient's outcome was unknown.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 22 year old female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported). Subsequently the patient experienced a rash on her neck and chest the same day as the vaccination. Subsequently, the patient recovered from rash on neck and rash on chest. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with all three doses of GARDASIL (lot numbers unspecified).  The patient had all negative Pap tests prior to vaccination.  After vaccination, the patient's Pap test came back as positive for high risk papillomavirus.  No other information is provided.  The patient sought unspecified medical treatment in the office.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2008. Information has been received from a physician concerning a 12 year old female with concomitant medications and pertinent medical history reported as unspecified, who on approximately 02-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot:634535/0960F).  0.5 ml IM. The second dose of GARDASIL was given on 02-APR-2008 (Lot # not reported).  Following the first dose she did not get a period for 5 months (she has had her period since age 11).  She sought the medical attention of a physician and her mother refused to allow her to take a pregnancy test.  The outcome was unspecified.  No product quality complaint was involved.  Additional information has been requested. Followup information was received from the physician who reported that the patient had no mentrual cycle for 5 months from AUG-2007 until approximately JAN-2008. It was reported that she recovered in approximately JAN-2008.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Vaccine positive rechallenge, Vulvovaginal human papilloma virus infection
Clinical narrative: Information has been received from a physician concerning a 17 year old white female (weight 125#, height 62") who on 23-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot #658558/1061U), IM. On 18-OCT-2007, the patient was vaccinated with the second dose of GARDASIL (Lot #658488/1264U), IM in the left arm. On 26-FEB-2008, the patient was vaccinated with the third dose of GARDASIL (Lot #659182/1757U), IM in the left arm. Concomitant medication was not reported. The physician reported that the patient experienced an increased outbreak of vulvar venereal warts after each injection. It was noted that at the time of vaccinations the patient had no warts and had no prior treatment for warts. The outcome and causality of the events were not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Dizziness, Laboratory test, Oral contraception, Syncope
Clinical narrative: Information has been received from a 22 year old female with no pertinent medical history, who on 14-JUN-2007 was vaccinated with a first dose of GARDASIL.  Concomitant therapy included ORTHO TRI-CYCLEN.  On 17-JUN-2007 the patient fainted.  The patient went to the emergency room and was later released.  Subsequently, the patient recovered.  In August 2007, the patient was vaccinated with a second dose of GARDASIL.  In August 2007 2 weeks after vaccination, the patient experienced fainted.  Subsequently, the patient recovered.  In March 2008, the patient was vaccinated with a second dose of GARDASIL.  In approximately March 2008, 3 weeks after vaccination, the patient experienced fainted.  The patient was seen by a physician.  Unspecified blood tests and computed axial tomography were performed (results not reported).  At the time of the report, the patient was recovering.  She reported that she "still feels like fainting and dizzy."  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a 22 year old female with no pertinent medical history, who on 14-JUN-2007 was vaccinated with a first dose of GARDASIL.  Concomitant therapy included ORTHO TRI-CYCLEN.  On 17-JUN-2007 the patient fainted.  The patient went to the emergency room and was later released.  Subsequently, the patient recovered.  In August 2007, the patient was vaccinated with a second dose of GARDASIL.  In August 2007 2 weeks after vaccination, the patient experienced fainted.  Subsequently, the patient recovered.  In March 2008, the patient was vaccinated with a second dose of GARDASIL.  In approximately March 2008, 3 weeks after vaccination, the patient experienced fainted.  The patient was seen by a physician.  Unspecified blood tests and computed axial tomography were performed (results not reported).  At the time of the report, the patient was recovering.  She reported that she "still feels like fainting and dizzy."  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Syncope
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not provided).  She received this dose at an office and the morning after receiving the vaccine she fainted.  At the end of October 2007, the patient was vaccinated with her second dose of GARDASIL (lot# 658558/1061U).  She experienced fatigue and felt generally weak.  She also received the third dose of GARDASIL (lot#658563/1063U) at the end of February or beginning of March 2008.  The patient had no adverse symptoms after this dose.  Her outcome was not reported.  Additional information has been requested.