chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Headache, Hypoglycaemia, Metabolic function test, Muscle twitching
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with hypoglycaemia, anxiety and light headedness and a history of syncope episodes who on 15-JAN-2010 was vaccinated with the third dose of GARDASIL. Concomitant therapy included anxiety medication (name unspecified). Seven days later, on 22-JAN-2010, the patient experienced chest pain, shortness of breath, nausea, headache, walking slowly, twitching eyes, abdominal pain and was taken to ER. Multiple tests were performed and everything came back normal.  The patient was referred to the rheumatologist, psychologist and cardiologist. On 25-JAN-2010 the patient was taken again to the ER with the same symptoms. Tests were performed and everything came back to normal again. Lab tests included electroencephalography, electrocardiogram, numerous blood tests like comprehensive metabolic panel, C-reactive protein thyroid, other blood tests: everything came back normal. It was noted that the patient's parents want to reported this because they thought that the syncope episode, hypoglycemia and light headedness worsened after their daughter received GARDASIL. It was noted that the patient was fine after the first and second GARDASIL dose. At the time of the report the patient had not recovered. Additional information has been requested. On 22-JAN-2010, the patient was taken to ER, and on 25-JAN-2010 was taken to another ER.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope, Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with hypoglycaemia, anxiety and light headedness and a history of syncope episodes who on 15-JAN-2010 was vaccinated with the third dose of GARDASIL. Concomitant therapy included anxiety medication (name unspecified). Seven days later, on 22-JAN-2010, the patient experienced chest pain, shortness of breath, nausea, headache, walking slowly, twitching eyes, abdominal pain and was taken to ER. Multiple tests were performed and everything came back normal.  The patient was referred to the rheumatologist, psychologist and cardiologist. On 25-JAN-2010 the patient was taken again to the ER with the same symptoms. Tests were performed and everything came back to normal again. Lab tests included electroencephalography, electrocardiogram, numerous blood tests like comprehensive metabolic panel, C-reactive protein thyroid, other blood tests: everything came back normal. It was noted that the patient's parents want to reported this because they thought that the syncope episode, hypoglycemia and light headedness worsened after their daughter received GARDASIL. It was noted that the patient was fine after the first and second GARDASIL dose. At the time of the report the patient had not recovered. Additional information has been requested. On 22-JAN-2010, the patient was taken to ER, and on 25-JAN-2010 was taken to another ER.
Sex: F
Vaccine: HPV4
Symptoms: Movement disorder
Clinical narrative: Information has been received from an anonymous consumer concerning her daughter who in October 2008, was vaccinated with the first dose of GARDASIL (LOT#, route not reported). Then after 2 weeks, the patient experienced a "movement disorder". The reporter refused to give any additional information. No further information is available.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ultrasound antenatal screen, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 32 year old female patient with no known drug reaction or allergies and a history in 2007, of papanicolaou smear abnormal with surgery and dislocated knee repair and a sister with multiple sclerosis who on 07-JAN-2010 was intramuscularly vaccinated with a 0.5 mL dose of GARDASIL (Lot # 0669Y) instead of H1N1 flu vaccine. Concomitant therapy included prenatal vitamins (unspecified), FLONASE, BENADRYL and SUDAFED prior to realizing that she was pregnant. It was reported that on 07-JAN-2010, the patient had 10 weeks of gestation, the patient LMP was on 27-OCT-2009 and the estimated date of delivery (EDD) is 03-AUG-2010. The patient had been followed since the vaccination by a maternal fetal medicine specialist. At 13 weeks of gestation, on approximately 26-JAN-2010 a routine First trimester screen blood test was performed, the result was normal. At 17 weeks of gestation, on approximately 23-JAN-2010, a sonogram was performed which showed echogenic foci in the left cardiac ventricle of the fetus. There were no adverse symptoms noted on the patient. Follow up information was received from the nurse practitioner which reported that the patient with allergy and a history of one previous pregnancy and one previous full term delivery and cryosurgery in 2000 due to abnormal papanicolaou smear who on 28-JAN-2010, had ultrasound done for screening which was within normal limits. On 25-FEB-2010, maternal serum alpha-fetoprotein (MSAFP) was within normal limits. There was no previous birth defect. At the time of reporting, the outcome was unknown. The baby's experience has been captured in WAES 1003USA00456B1. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female with no pertinent medical history and no drug allergies, who "2 years ago", was vaccinated with the first dose of GARDASIL (0.5ml, IM). On 23-FEB-2010 the patient received the second dose (0.5ml, IM, lot # 662765/1353Y). There was no concomitant medication. The patient experienced the onset of dizziness 5 minutes after receiving her second dose on 23-FEB-2010. Paramedics were called to the office and the patient was evaluated. The patient was found to be stable and was released to home with her mother. There were no labs or diagnostic tests performed. The patient had declined to continue the vaccine series. The patient went in office for medical attention. The dizziness resolved by that evening of 23-FEB-2010 without requiring treatment. Follow up information has been received from a medical assistant concerning an 18 year old female who on 23-FEB-2010 at 4:00 PM received the second dose of GARDASIL (IM, lot # 662765/1353Y) in the left deltoid. On 23-FEB-2010 at 4:05 PM the patient experienced dizziness and nausea for approximately 6 to 10 hours following injection. The patient required doctor room visit and recovered on 24-FEB-2010. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal cardiac disorder, Ultrasound foetal, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was exposed through the mother on 07-JAN-2010 was intramuscularly vaccinated with a 0.5 mL dose of GARDASIL (Lot # 0669Y) instead of H1N1 flu vaccine. Concomitant therapy included prenatal vitamins (unspecified), FLONASE, BENADRYL and SUDAFED prior to realizing that she was pregnant. The nurse practitioner reported that at 17 weeks of gestation, on approximately 23-JAN-2010, a sonogram was performed which showed echogenic foci in the left cardiac ventricle of the fetus. The nurse practitioner felt that echogenic foci in the left cardiac ventricle was not related to therapy with GARDASIL. At the time of the report the patient's outcome was unknown. Follow up information was received from the nurse practitioner which reported that on 28-JAN-2010, the patient's mother had ultrasound done for screening which was within normal limits. On 25-FEB-2010, maternal serum alpha-fetoprotein (MSAFP) was within normal limits. The mother's experience has been captured in WAES# 1003USA00456. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Amenorrhoea, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with unspecified medical history, drug reactions or allergies, who in "November" (year unspecified), was vaccinated with a 0.5 mL dose of GARDASIL, intramuscular route (lot # unknown). Concomitant therapy included MENACTRA administered at same time with GARDASIL. The physician reported that "in September", the patient began her first menstrual cycle and since the patient received GARDASIL and MENACTRA she had no experienced a menstruation. Lab diagnostic studies performed were unspecified. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old patient who on 01-MAR-2010 was vaccinated with her first dose of GARDASIL (Lot # 663559/1178Y). Concomitant therapy included ORTHOTRI-CYCLEN LO. On 02-MAR-2010 the patient experienced a "red rash on the upper portion of her body" after she was given the first dose of GARDASIL. The patient was told to take BENADRYL on 02-MAR-2010 but she did not take it until "last night", on 02-MAR-2010. It was reported that the patient took BENADRYL 25 mg that night. The patient called the physician's office on 03-MAR-2010 and stated that the rash was "raised, red and itchy and has now spread". The registered nurse also reported that the patient stated that the injection site was not red but on 03-MAR-2010 the injection site appeared to be red. On 03-MAR-2010 the patient was advised to take 50 mg of BENADRYL. At the time of the report, the patient had not recovered. Follow up information has been received from a physician who indicated that the female patient with no illness at time of vaccination, no pre-existing allergies, birth defects, medical conditions was vaccinated with the first dose of GARDASIL at her left arm at 10:17 a.m. On 02-MAR-2010 at 12:00 a.m. the patient developed red rash on upper body which started first and then to injection site and developed slight redness, self limiting. On 07-MAR-2010 the patient recovered. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a Healthcare Worker concerning a 23 year old female patient with no pertinent medical history and no drug reactions/allergies, who on 30-DEC-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 665547/1318Y). On 24-FEB-2010, the patient was vaccinated with the second dose of GARDASIL. Concomitant therapy included unspecified oral contraceptives. It was reported that on 25-FEB-2010, after receiving the second dose of GARDASIL, the patient developed itching and a small lump on her left arm at the injection site. At the time of the report, the patient had not recovered. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from the Healthcare Worker who reported that the patient with no pre-existing allergies, birth defects or medical conditions, on 24-FEB-2010 was vaccinated with the second dose of GARDASIL. It was stated that the patient called on 01-MAR-2010 with complaints of soreness at the injection site, "small bump" (7-8 mm of diameter). The patient was advised to go into the office to be seen right away. On 03-MAR-2010, the patient went to the office when the dime sized indurated tender bump felt at the injection site. It was reported that the patient stated that it was slightly larger before. No other problems or findings were reported. No laboratory diagnostic studies were performed. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Colitis ulcerative
Clinical narrative: Information has been received from a physician concerning a female attended the same church who completed the GARDASIL injection series and developed ulcerative colitis.  It was unknown if the patient had sought medical attention.  At the time of report the patient's status was unknown.  The girl was not a patient of the physician.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with the first dose of GARDASIL (lot number not reported), 0.5ml via intramuscular. There were no concomitant medications reported. No pertinent medical history reported. A nurse reported that the patient received the first dose of GARDASIL and experienced muscle pain in her lower back and her legs. No further information provided. On unspecified date, the patient sought unspecified medical attention. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dry mouth, Immediate post-injection reaction, Nausea, Tremor
Clinical narrative: Information has been received from a nurse concerning a 22 year old female with a history of sulfonamide allergy with no pertinent medical history, who on 02-MAR-2009 was vaccinated IM with 0.5 ml first dose of GARDASIL (lot number: 0981Y). There was no concomitant medication. The nurse stated that the patient received the first dose of GARDASIL and immediately stated she was dizzy. The patient called to the physician's office and she stated that she was nauseated, light headed, shaky and had a dry mouth and she did not experienced fever on 03-MAR-2010. No laboratory test was performed. At the time of the report the outcome of the patient was not recovered. The patient sought unspecified medical attention. Follow up information has been received from the nurse concerning the 22 year old female patient who on 02-MAR-2009, at 13:00, was vaccinated IM with 0.5ml first dose of GARDASIL (lot number: 0981Y). On 03-MAR-2010 the patient developed nausea, shaky and light-headed. The patient had no fever. At the time of this report, the patient had recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who in approximately 2007 (2 to 3 years ago) was vaccinated with the first dose of GARDASIL. The patient had not been given any other doses of GARDASIL vaccine. Subsequently the patient became sexually active and had abnormal cervical cells and possible HPV. At the time of the report, the patient's status was unknown. Follow-up information has been received from the physician. The physician reported that he could not recall the patient's name, although, reported that the patient was only 'partially dosed' and inquired if the patient needed to restart the vaccination series. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, Influenza like illness, Injection site erythema, Pain
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female who on 29-SEP-2009 was vaccinated with GARDASIL (lot number 663453/0249Y) via intramuscular into the left arm. No pertinent medical history and drug reactions/allergies provided. There were no concomitant medications reported. On 29-SEP-2009, that night the patient had a fever of 102.4 F which lasted for 3 days, along with body aches, headache, and flu-like symptoms. Also there was a slight redness around the injection site. Subsequently, the patient recovered from fever of 102.4 F, body aches, headache, flu-like symptoms and a slight redness around the injection site. No lab diagnostics studies were performed. On 02-OCT-2009, the patient fully recovered. On unspecified date, the patient sought unspecified medical attention. No further information is available. Follow-up information was received from a physician who reported that a female student with no known allergies who on 29-SEP-2009 was vaccinated with GARDASIL, intramuscular 0.5 ml (lot number 663453/0249Y). The patient had no previous exposure to this or related drug. That evening, the patient had fever 102.4, continued with fever X 3 days. The patient had body aches and headache. The patient had no vomit or diarrhea or ST. The patient had slight redness around injection site. All symptoms went after the 3 days. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female who on 29-SEP-2009 was vaccinated with GARDASIL (lot number 663453/0249Y) via intramuscular into the left arm. No pertinent medical history and drug reactions/allergies provided. There were no concomitant medications reported. On 29-SEP-2009, that night the patient had a fever of 102.4 F which lasted for 3 days, along with body aches, headache, and flu-like symptoms. Also there was a slight redness around the injection site. Subsequently, the patient recovered from fever of 102.4 F, body aches, headache, flu-like symptoms and a slight redness around the injection site. No lab diagnostics studies were performed. On 02-OCT-2009, the patient fully recovered. On unspecified date, the patient sought unspecified medical attention. No further information is available. Follow-up information was received from a physician who reported that a female student with no known allergies who on 29-SEP-2009 was vaccinated with GARDASIL, intramuscular 0.5 ml (lot number 663453/0249Y). The patient had no previous exposure to this or related drug. That evening, the patient had fever 102.4, continued with fever X 3 days. The patient had body aches and headache. The patient had no vomit or diarrhea or ST. The patient had slight redness around injection site. All symptoms went after the 3 days. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no known drug allergies who on 29-DEC-2009 and 17-FEB-2010 was vaccinated with a first and second (lot # 661953/1130X) doses of GARDASIL. There was no concomitant medication. On 17-FEB-2010 the patient experienced a headache that had lasted for five days. The physician reported that the patient did miss school for the headaches she was having, but the physician did not mention if the patient had recovered as of yet. The physician also reported that the patient was just prescribed YAZ (manufacturer unspecified) around the same time of getting GARDASIL but it was unknown of the patient started taking YAZ (manufacturer unspecified). The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. Follow up information has been received from a healthcare professional concerning a 15 year old female student who on 17-FEB-2010, at 13:00, was vaccinated with a second (lot # 661953/1130X) dose of GARDASIL into right deltoid. The patient called on 22-FEB-2010 stated she experienced "non-stop" headache since she received injection. She missed school. The headache resolved on Saturday morning 20-FEB-2010. Follow up information has been received from a healthcare professional who reported that on 22-FEB-2010 (previously reported as 17-FEB-2010) the patient experienced headache lasting 2 days (previously reported as 4 days) and recovered. Additional information is not expected.
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Syphilis, Treponema test positive
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old male patient with an allergy to tobramycin and a history of wisdom teeth extraction in 2007, reconstructive surgery left shoulder in 2006 and eye surgery at age 3 who on 03-FEB-2010 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (lot # 662529/1317Y).  Concomitant therapy included multivitamins from 2006 and (ELOCON lotion) from October 2009.  Subsequently, the patient had a positive syphilis test.  It was reported that the patient had no symptoms.  The patient was being treated with 3 doses of penicillin.  The first dose of penicillin was given last Friday, the second dose today (26-FEB-2010), and the third dose will be given next week.  The patient sought medical attention via visit to health center.  At the time of the report, the patient was in treatment.  Follow-up information has been received from a nurse practitioner concerning the 21 year old student with tobramycin allergy who at 10 am on 03-FEB-2010 was vaccinated intramuscularly with a dose of GARDASIL (lot# 662529/1317Y) into his left arm.  On 17-FEB-2010, the RPR performed positive (1:1) and FTA-ABS showed reactive at 2:45 PM.  On 26-FEB-2010, the RPR performed positive (1:1) too, but the FTA-ABS showed non reactive.  It was reported that there was no symptoms but the abnormal lab testing done to screen for STD sexually transmitted disease (STD) in low risk patient.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Cytomegalovirus test positive, Differential white blood cell count normal, Fatigue
Clinical narrative: Information has been received from a Nurse Practitioner student concerning a 15 year old female patient with chlamydial infection and bipolar disorder and with no known drug allergies, who on 01-MAR-2010 was vaccinated with a first dose of GARDASIL (intramuscular route, lot # 661764/0650X). Concomitant therapy included DEPO-PROVERA, lithium and SEROQUEL. The patient was seen by the nurse practitioner two weeks after she had received the vaccination, at that visit the patient's mother reported that "about two days after" receiving GARDASIL, on 03-MAR-2010, the patient developed viral like symptoms. The Nurse Practitioner reported that since approximately 06-MAR-2010, the patient experienced muscle aches, pain in the anterior thighs and generalized fatigue; the Nurse Practitioner also stated that at that time the patient had blood work drawn on that day to rule-out hepatitis and the patient's liver enzymes were elevated. The patient's CBC result was normal, SGOT was 184 and the SGTP was 279. The Nurse Practitioner reported that the Chlamydia infection had been treated with an antibiotic (unspecified) (also reported that the patient was treated with erythromycin for treatment of Chlamydia). The Nurse Practitioner did not know if the patient's "viral syndrome" was related to GARDASIL. The patient was seen again on 23-MAR-2010 because her viral symptoms had worsened and as of that date the patient had not recovered. Follow up information has been received from the Nurse Practitioner who reported that the patient tested positive for Cytomegalovirus and that the virus was self-limiting and there was no treatment. The Nurse Practitioner stated that the patient was clinically feeling better and that the patient did not have hepatitis. On 05-APR-2010, liver function blood studies were repeating with unspecified results. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Hepatic enzyme increased, Liver function test, Mononucleosis heterophile test negative, Myalgia
Clinical narrative: Information has been received from a Nurse Practitioner student concerning a 15 year old female patient with chlamydial infection and bipolar disorder and with no known drug allergies, who on 01-MAR-2010 was vaccinated with a first dose of GARDASIL (intramuscular route, lot # 661764/0650X). Concomitant therapy included DEPO-PROVERA, lithium and SEROQUEL. The patient was seen by the nurse practitioner two weeks after she had received the vaccination, at that visit the patient's mother reported that "about two days after" receiving GARDASIL, on 03-MAR-2010, the patient developed viral like symptoms. The Nurse Practitioner reported that since approximately 06-MAR-2010, the patient experienced muscle aches, pain in the anterior thighs and generalized fatigue; the Nurse Practitioner also stated that at that time the patient had blood work drawn on that day to rule-out hepatitis and the patient's liver enzymes were elevated. The patient's CBC result was normal, SGOT was 184 and the SGTP was 279. The Nurse Practitioner reported that the Chlamydia infection had been treated with an antibiotic (unspecified) (also reported that the patient was treated with erythromycin for treatment of Chlamydia). The Nurse Practitioner did not know if the patient's "viral syndrome" was related to GARDASIL. The patient was seen again on 23-MAR-2010 because her viral symptoms had worsened and as of that date the patient had not recovered. Follow up information has been received from the Nurse Practitioner who reported that the patient tested positive for Cytomegalovirus and that the virus was self-limiting and there was no treatment. The Nurse Practitioner stated that the patient was clinically feeling better and that the patient did not have hepatitis. On 05-APR-2010, liver function blood studies were repeating with unspecified results. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Viral infection
Clinical narrative: Information has been received from a Nurse Practitioner student concerning a 15 year old female patient with chlamydial infection and bipolar disorder and with no known drug allergies, who on 01-MAR-2010 was vaccinated with a first dose of GARDASIL (intramuscular route, lot # 661764/0650X). Concomitant therapy included DEPO-PROVERA, lithium and SEROQUEL. The patient was seen by the nurse practitioner two weeks after she had received the vaccination, at that visit the patient's mother reported that "about two days after" receiving GARDASIL, on 03-MAR-2010, the patient developed viral like symptoms. The Nurse Practitioner reported that since approximately 06-MAR-2010, the patient experienced muscle aches, pain in the anterior thighs and generalized fatigue; the Nurse Practitioner also stated that at that time the patient had blood work drawn on that day to rule-out hepatitis and the patient's liver enzymes were elevated. The patient's CBC result was normal, SGOT was 184 and the SGTP was 279. The Nurse Practitioner reported that the Chlamydia infection had been treated with an antibiotic (unspecified) (also reported that the patient was treated with erythromycin for treatment of Chlamydia). The Nurse Practitioner did not know if the patient's "viral syndrome" was related to GARDASIL. The patient was seen again on 23-MAR-2010 because her viral symptoms had worsened and as of that date the patient had not recovered. Follow up information has been received from the Nurse Practitioner who reported that the patient tested positive for Cytomegalovirus and that the virus was self-limiting and there was no treatment. The Nurse Practitioner stated that the patient was clinically feeling better and that the patient did not have hepatitis. On 05-APR-2010, liver function blood studies were repeating with unspecified results. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a consumer concerning her daughter a female patient who was vaccinated with 3 dose of GARDASIL (lot numbers not reported) "about a year and a half ago". "Currently" the patient had bumps at the injection site. Neither her physician nor her dermatologist knew what the cause was but the patient may be getting a biopsy. No other details. The patient was not recovered. On unspecified date, the patient sought unspecified medical attention via office visit. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Drug administered at inappropriate site, Injection site pain
Clinical narrative: Information has been received from a Registered Nurse concerning a female who was vaccinated with one dose of GARDASIL (lot number not reported) in the gluteal region and 2 doses of GARDASIL (lot number not reported) in her deltoid. The patient said she did not experience pain when it was given in the gluteal region but she did have injection site pain when it was administered in the deltoid. Subsequently, the patient recovered from injection site pain. Follow-up information was received from a Registered Nurse concerning a 22 year old female student who on 30-OCT-2007 was vaccinated with the first dose of GARDASIL (lot number 655154/1210U), intramuscular into left gluteal. The patient had no previous exposure to this or related vaccine. While the patient was in the clinic, she described discomfort of GARDASIL shots, "they were the worst! Except for the first one I got in the butt. I didn't feel that one at all." The patient was informed that injection did not indicate for that site to the nurse's knowledge. The patient stated that she would try to obtain further information on this. Subsequently, the patient recovered. No further information is available. This is one of two reports received from the same source.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 32 year old female who on 25-FEB-2010 was vaccinated with the third dose of GARDASIL. The vaccination dates of the first 0.5ml dose and the second dose were not reported. It was reported that the patient experienced diarrhea and vomiting after getting the first and the third dose. The patient did not experience any AE after the second dose. The patient received unspecified medical attention. The outcome was not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 05-SEP-2008 was vaccinated with the second dose of GARDASIL and on 25-NOV-2008 she received her third dose. She was recently tested positive for HPV. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Joint swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no pertinent medical history, no drug reactions or allergies reported, who in June 2009 and in August 2009, was vaccinated with the first and second doses of GARDASIL (route and lot # unknown) respectively. There was no concomitant medication. On an unspecified date, the patient experienced swelling and pain in her knee after receiving the second dose of GARDASIL. No lab diagnostic studies were performed. The patient sought unspecified medical attention. At the time of the report the patient was recovering. Follow-up information was received from the physician who reported that on 18-JUN-2009, the patient received the first dose of GARDASIL (lot # 662300/0100Y) and on 24-AUG-2009, the patient received the second dose of GARDASIL (lot # 662404/0312Y). There were no concomitant vaccines given. The physician reported that the patient experienced "gradual" swelling and pain in her knee after days to weeks from the second dose of GARDASIL. There was no serious criteria. The physician stated that the patient was very active in sports. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Information has been received from a health profession concerning a 13 year old female with no pertinent medical history reported who on 17-FEB-2010 was vaccinated intramuscularly into the left deltoid with second dose of GARDASIL (lot number 663454/0672Y). On 18-FEB-2010, the patient experienced swollen itchy eyes. The patient recovered from swollen itchy eyes on 19-FEB-2010. The patient did not seek medical attention. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Fungal infection, Oropharyngeal pain, Pyrexia, Rash pruritic
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female patient with allergy to ULTRAM, NEURONTIN, tramadol hydrochloride (unspecified), PERCODAN, VICODIN and atropine sulfate and no pertinent medical history who on 18-MAR-2010, was vaccinated with a 0.5 ml IM dose of GARDASIL (lot # 663573/0969Y). Concomitant therapy included amoxicillin, ERYTHROCIN, BACTRIM DS, and ALLERGY DROPS. On 18-MAR-2010 or 19-MAR-2010, the patient experienced a pruritic rash on her neck and left upper chest, a yeast infection for two days, dysphagia, tightness of throat, sore throat and fever. The patient was treated with BENADRYL and MONISTAT. No lab diagnostics studies were performed. At the time of reporting, the outcome was unknown. The patient sought medical attention via office visit. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Throat tightness
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female patient with allergy to ULTRAM, NEURONTIN, tramadol hydrochloride (unspecified), PERCODAN, VICODIN and atropine sulfate and no pertinent medical history who on 18-MAR-2010, was vaccinated with a 0.5 ml IM dose of GARDASIL (lot # 663573/0969Y). Concomitant therapy included amoxicillin, ERYTHROCIN, BACTRIM DS, and ALLERGY DROPS. On 18-MAR-2010 or 19-MAR-2010, the patient experienced a pruritic rash on her neck and left upper chest, a yeast infection for two days, dysphagia, tightness of throat, sore throat and fever. The patient was treated with BENADRYL and MONISTAT. No lab diagnostics studies were performed. At the time of reporting, the outcome was unknown. The patient sought medical attention via office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Jaw fracture, Syncope
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, after received the GARDASIL, the patient fainted, fell and broke her jaw. It was unspecified if the patient sought medical attention and if lab tests were performed. At the time of the report, the patient's outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several cases reported by the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a female who on an unknown date was vaccinated with a dose of GARDASIL. Subsequently the patient experienced hair loss. The outcome of the event was not reported. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: HPV4
Symptoms: Body temperature increased, Nasal congestion, Nasopharyngitis
Clinical narrative: Information has been received from a medical assistant concerning a 26 year old patient with no drug allergies and no pertinent medical history who on 10-NOV-2009 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (LOT# 663452/0671Y). There was no concomitant medication. On 11-NOV-2009 the patient experienced temperature, stuffy nose and "felt like she had a cold". The patient received the second dose of GARDASIL (LOT# 662304/1013Y) late on 23-MAR-2010. There was no lab diagnostic performed. The patient had an office visit for the second dose of GARDASIL. On an unspecified date, the patient recovered from temperature, stuffy nose and "felt like she had a cold". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). The physician reported that the patient had "a file full of problems that she had incurred as a result of taking the vaccine". The physician did not provide what the specific problems were.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a licensed practical nurse, concerning a female patient, who on an unknown date, was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). On an unknown date "few months ago", the patient experienced a possible paralysis several weeks after receiving GARDASIL. It was also stated that the patient did not experience the paralysis in the nurse's office but in other physician office. In follow-up, the administrator of the office where the event occurred, stated that no one was paralyzed, that they had a patient in their office who in summer 2007, had some numbness after receiving GARDASIL. The patient's outcome was unknown at the time of reporting. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name, healthcare provider name and contact information. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anti-cyclic citrullinated peptide antibody positive, Arthralgia, Blood uric acid, C-reactive protein increased, Hypergammaglobulinaemia
Clinical narrative: Information has been received from a physician's assistant concerning a 21 year old female patient who on 19-JUL-2007 was vaccinated with a 0.5 mL dose of GARDASIL.  On 13-JUN-2008 the patient was diagnosed with rheumatoid arthritis.  It was unknown if the patient sought medical attention.  Therapy with GARDASIL was discontinued.  At the time of the report, the patient had not recovered from this event.  Follow-up information has been received from a nurse concerning a patient with seasonal allergies, no known drug allergy, no history of an infectious process before the start of the rheumatoid arthritis symptoms and no family history of any autoimmune disorder.  Concomitant therapy included ALLEGRA.  There were no other vaccines given at that time.  The patient presented to the office on 22-MAY-2008 with swollen knuckles.  The rheumatoid arthritis diagnostics panel was drawn that day results:  C-Reaction Protein 11.2; Erythrocyte Sedimentation Rate (sed rate) 32,; uric acid was normal.  On 21-JUL-2008 the sed rate was normal at 7, but the sed rate was back up to 33 in October 2008.  The patient was treated with methotrexate and prednisone.  It was stated that there was no serious criteria.  At the time of the report, the patient's outcome was unknown.  Follow-up information has been received from the physician's assistant concerning the 21 year female patient with no pre-existing allergies (previously reported with seasonal allergies) and no illness at time of vaccination.  The patient was vaccinated with the first dose of GARDASIL at 12:20 pm on 19-JUL-2007.  In July 2007 (previously reported as 13-JUN-2008) the patient experienced joint pain, swelling and stiffness.  On 27-JUN-2008, the patient was diagnosed with rheumatoid arthritis.  The patient's sed rate showed 34.  The interleukin-6 result was 11.3.  The patient's CCP exceeded 250.  The serum electrophoresis showed polyclonal hyper gamma global erema.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Interleukin level, Joint stiffness, Joint swelling, Laboratory test normal, Protein total increased
Clinical narrative: Information has been received from a physician's assistant concerning a 21 year old female patient who on 19-JUL-2007 was vaccinated with a 0.5 mL dose of GARDASIL.  On 13-JUN-2008 the patient was diagnosed with rheumatoid arthritis.  It was unknown if the patient sought medical attention.  Therapy with GARDASIL was discontinued.  At the time of the report, the patient had not recovered from this event.  Follow-up information has been received from a nurse concerning a patient with seasonal allergies, no known drug allergy, no history of an infectious process before the start of the rheumatoid arthritis symptoms and no family history of any autoimmune disorder.  Concomitant therapy included ALLEGRA.  There were no other vaccines given at that time.  The patient presented to the office on 22-MAY-2008 with swollen knuckles.  The rheumatoid arthritis diagnostics panel was drawn that day results:  C-Reaction Protein 11.2; Erythrocyte Sedimentation Rate (sed rate) 32,; uric acid was normal.  On 21-JUL-2008 the sed rate was normal at 7, but the sed rate was back up to 33 in October 2008.  The patient was treated with methotrexate and prednisone.  It was stated that there was no serious criteria.  At the time of the report, the patient's outcome was unknown.  Follow-up information has been received from the physician's assistant concerning the 21 year female patient with no pre-existing allergies (previously reported with seasonal allergies) and no illness at time of vaccination.  The patient was vaccinated with the first dose of GARDASIL at 12:20 pm on 19-JUL-2007.  In July 2007 (previously reported as 13-JUN-2008) the patient experienced joint pain, swelling and stiffness.  On 27-JUN-2008, the patient was diagnosed with rheumatoid arthritis.  The patient's sed rate showed 34.  The interleukin-6 result was 11.3.  The patient's CCP exceeded 250.  The serum electrophoresis showed polyclonal hyper gamma global erema.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell count increased, Rheumatoid arthritis
Clinical narrative: Information has been received from a physician's assistant concerning a 21 year old female patient who on 19-JUL-2007 was vaccinated with a 0.5 mL dose of GARDASIL.  On 13-JUN-2008 the patient was diagnosed with rheumatoid arthritis.  It was unknown if the patient sought medical attention.  Therapy with GARDASIL was discontinued.  At the time of the report, the patient had not recovered from this event.  Follow-up information has been received from a nurse concerning a patient with seasonal allergies, no known drug allergy, no history of an infectious process before the start of the rheumatoid arthritis symptoms and no family history of any autoimmune disorder.  Concomitant therapy included ALLEGRA.  There were no other vaccines given at that time.  The patient presented to the office on 22-MAY-2008 with swollen knuckles.  The rheumatoid arthritis diagnostics panel was drawn that day results:  C-Reaction Protein 11.2; Erythrocyte Sedimentation Rate (sed rate) 32,; uric acid was normal.  On 21-JUL-2008 the sed rate was normal at 7, but the sed rate was back up to 33 in October 2008.  The patient was treated with methotrexate and prednisone.  It was stated that there was no serious criteria.  At the time of the report, the patient's outcome was unknown.  Follow-up information has been received from the physician's assistant concerning the 21 year female patient with no pre-existing allergies (previously reported with seasonal allergies) and no illness at time of vaccination.  The patient was vaccinated with the first dose of GARDASIL at 12:20 pm on 19-JUL-2007.  In July 2007 (previously reported as 13-JUN-2008) the patient experienced joint pain, swelling and stiffness.  On 27-JUN-2008, the patient was diagnosed with rheumatoid arthritis.  The patient's sed rate showed 34.  The interleukin-6 result was 11.3.  The patient's CCP exceeded 250.  The serum electrophoresis showed polyclonal hyper gamma global erema.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female patient who on 23-MAR-2010 was vaccinated with the first 0.5mL dose of GARDASIL. On 24-MAR-2010 the patient woke up with a rash on her back. The patient had a doctor's appointment on 24-MAR-2010. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a consumer concerning her daughter, who in May 2009, was vaccinated with the first dose of GARDASIL (dose, route and lot number not provided). On 09-FEB-2010, the patient received her third dose of GARDASIL (dose, route and lot number not provided). On 14-FEB-2010, the patient started experiencing joint pain in her middle fingers "around the same time she started taking birth control pills". It was unknown if the patient sought medical attention. At the time of reporting, the patient was still experiencing the pain.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Ovarian cyst, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient with no pertinent medical history nor allergies who on 06-AUG-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# not reported).  On an unspecified date in November 2009 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# not reported).  There was no concomitant medication.  On 09-MAR-2010 the patient was diagnosed with a right ovarian cyst.  It was reported that the patient presented with abdominal pain and an ultrasound revealed a 2.5 cm right ovarian cyst.  Unspecified medical attention was sought.  The patient was referred to an unspecified gynecologist.  At the time of this report, the patient's ovarian cyst persisted.  Follow up information has been received from the physician who reported that he didn't think there was a vaccine adverse experience report that he had to do relating to the GARDASIL vaccine given.  What happened was, in the course of time on one of the patient's visit, she had to be work-up for a right lower abdominal pain.  Abdominal-pelvic ultrasound had to be done which revealed an ovarian cyst on the right side.  The physician stated that he didn't think it had anything to do with the patient receiving the GARDASIL vaccine and having an adverse event to report.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 22 year old female who on 09-MAR-2010 was vaccinated with the first dose of GARDASIL at 9:00 AM. On 09-MAR-2010, the patient experienced fever and shortness of breath at 18:00 PM. The patient sought unspecified medical attention. The reporter stated that the patient took TYLENOL and CLARITIN and then was fine. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dysplasia, Human papilloma virus test negative, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient with no pertinent medical history with CECLOR allergy who on 03-JUN-2009, 0n 12-AUG-200 and on 16-DEC-2009, was vaccinated with the first, second and third 0.5 mL doses of GARDASIL intramuscular route (lot # unknown). Concomitant therapy included unspecified birth control pills. On 03-MAR-2010, the patient had a pap smear which revealed low-grade dysplasia. On 21-JAN-2009, the patient had a normal pap smear and on 20-APR-2009 a HPV DNA test was performed with negative result. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. No further information is available.