chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Body temperature increased, Cough, Epstein-Barr virus test negative, Full blood count abnormal
Clinical narrative: Information has been received from a female consumer concerning her 18 year old daughter with no drug reactions/allergies and asthma and a history of mononucleosis (June 2009) who in August 2009, was vaccinated with her first dose of GARDASIL. Concomitant therapy included ALBUTEROL and ADVAIR. The consumer reported that on 04-SEP-2009, the patient developed "flu like symptoms" while she was at college. The patient was evaluated at the student health center and was diagnosed with "flu". The patient had the following symptoms, cough, sore throat and intermittent fever as high as 102.3F persisted. The patient came home from college on 27-OCT-2009 and was evaluated by the physician who recommended her to take multivitamins and vitamin C. On 11-NOV-2009, the patient was examined in a follow-up visit. A "strep test", "flu swab" and a "mono" test were performed which were negative. In addition, a complete blood count was performed and revealed anemia. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza, Influenza virus test negative, Mononucleosis heterophile test negative, Oropharyngeal pain, Pyrexia
Clinical narrative: Information has been received from a female consumer concerning her 18 year old daughter with no drug reactions/allergies and asthma and a history of mononucleosis (June 2009) who in August 2009, was vaccinated with her first dose of GARDASIL. Concomitant therapy included ALBUTEROL and ADVAIR. The consumer reported that on 04-SEP-2009, the patient developed "flu like symptoms" while she was at college. The patient was evaluated at the student health center and was diagnosed with "flu". The patient had the following symptoms, cough, sore throat and intermittent fever as high as 102.3F persisted. The patient came home from college on 27-OCT-2009 and was evaluated by the physician who recommended her to take multivitamins and vitamin C. On 11-NOV-2009, the patient was examined in a follow-up visit. A "strep test", "flu swab" and a "mono" test were performed which were negative. In addition, a complete blood count was performed and revealed anemia. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test negative
Clinical narrative: Information has been received from a female consumer concerning her 18 year old daughter with no drug reactions/allergies and asthma and a history of mononucleosis (June 2009) who in August 2009, was vaccinated with her first dose of GARDASIL. Concomitant therapy included ALBUTEROL and ADVAIR. The consumer reported that on 04-SEP-2009, the patient developed "flu like symptoms" while she was at college. The patient was evaluated at the student health center and was diagnosed with "flu". The patient had the following symptoms, cough, sore throat and intermittent fever as high as 102.3F persisted. The patient came home from college on 27-OCT-2009 and was evaluated by the physician who recommended her to take multivitamins and vitamin C. On 11-NOV-2009, the patient was examined in a follow-up visit. A "strep test", "flu swab" and a "mono" test were performed which were negative. In addition, a complete blood count was performed and revealed anemia. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site anaesthesia, Injection site reaction, Nausea, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 07-JUL-2009 was vaccinated with the first dose of GARDASIL (Lot number 658271/0558X). On 07-JUL-2009 the patient experienced a headache 2 hours after vaccination with nausea and vomiting. The patient also experienced tingling numbness in the arm where she had the injection. The patient reported these symptoms when she returned in September to receive the second dose of GARDASIL. The physician's office decided to not administer the second dose of GARDASIL at this time. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 07-JUL-2009 was vaccinated with the first dose of GARDASIL (Lot number 658271/0558X). On 07-JUL-2009 the patient experienced a headache 2 hours after vaccination with nausea and vomiting. The patient also experienced tingling numbness in the arm where she had the injection. The patient reported these symptoms when she returned in September to receive the second dose of GARDASIL. The physician's office decided to not administer the second dose of GARDASIL at this time. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from an 17 year old female consumer and her mother without pertinent medical history and with penicillin allergy who on 14-MAY-200 was vaccinated with the first dose of GARDASIL (route and lot # unknown). There was no concomitant medication. The patient experienced a little pain on the injection site that lasted for a week after receiving the first dose of GARDASIL. And when the patient received her second dose of GARDASIL "the last month", in October 2009, she developed the pain on the injection site again and she had the pain since the time she received the second dose. The patient's mother stated that the pain was still there when the patient moved her arm. No lab diagnostic studies performed. The patient did not seek medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female who "two weeks ago" on approximately 02-OCT-2009 was vaccinated with a first 0.5ml dose of GARDASIL (injection, lot# not reported). On approximately 02-OCT-2009 the patient fainted after getting the vaccine. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood test normal, Computerised tomogram normal, Cushingoid, Headache
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who in August 2009, was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). There were unknown concomitant therapies given. Within two weeks of receiving the first injection of GARDASIL, the patient developed malaise, neck swelling, headache, abdominal pain and Cushing's disease type symptoms. The patient had negative results on CT, MRI and blood work exams that were conducted. There was no hospitalization however the patient was reviewed by an emergency room physician, a pediatric endocrinology and a new internal medicine primary care physician. The patient was not required to be hospitalized. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Malaise, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who in August 2009, was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). There were unknown concomitant therapies given. Within two weeks of receiving the first injection of GARDASIL, the patient developed malaise, neck swelling, headache, abdominal pain and Cushing's disease type symptoms. The patient had negative results on CT, MRI and blood work exams that were conducted. There was no hospitalization however the patient was reviewed by an emergency room physician, a pediatric endocrinology and a new internal medicine primary care physician. The patient was not required to be hospitalized. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MEN, TTOX
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter who on 20-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot number not provided). Secondary suspect therapy included hepatitis A virus vaccine inactivated (manufacturer unknown). Concomitant vaccinations included tetanus toxoid (unspecified) and meningococcal vaccine (unspecified). Subsequently on 27-AUG-2009 the patient developed hives that were itchy and looked like bug bites on her legs and stomach and recently the patient started to have some lip swelling. The patient's mother reported that the patient was going to see an allergist but has not yet recovered. The patient sought medical attention. Follow up information has been received from the physician concerning the patient who was vaccinated with the first dose of GARDASIL (IM) lot# 663451/0261Y) on 20-AUG-2009. The patient's father stated that the patient had hives around the time of the vaccination. On 03-NOV-2009, the patient was vaccinated with the second dose of GARDASIL and there were no problems. At the time of the report, the patient had recovered on an unspecified date. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal weight gain, Alpha 1 foetoprotein normal, Anaemia of pregnancy, Beta haemolytic streptococcal infection, Cholestasis of pregnancy
Clinical narrative: Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female with no pertinent medical history and no drug reactions/allergies who on 01-SEP-2009 was vaccinated with the first dose of GARDASIL (0.5ml, IM, 662229/1497X). There was no concomitant medication. The patient was 3 weeks pregnant when she was vaccinated. The patient had ultrasound to confirm pregnancy. The estimated due date would be on 21-MAY-2010. At the time of reporting the patient was pregnant. Follow up information has been received from the physician assistant concerning a 19 year old female with no significant past medical history, no concurrent medical conditions and no previous pregnancies who on 01-SEP-2009 was vaccinated with a dose of GARDASIL (lot# 662229/1497X) in her left deltoid. Concomitant therapy include prenatal vitamin daily for pregnancy in September 2009. On 15-OCT-2009 ultrasound was performed to confirm the pregnancy and the result was normal. The patient's LMP was reported as 11-AUG-2009 and the EDD was reported as 21-MAY-2010. No adverse event known. At the time of the report the outcome was unknown. Follow up information has been received from a physician's assistant concerning a 19 year old female who had one previous pregnancy and one full term delivery (40 4/7 weeks from LMP). There was no birth defect and no infant complications in previous pregnancy. On 01-SEP-2009, the patient was vaccinated with the first dose of GARDASIL (lot# 662229/1497X). Concomitant therapy include prenatal vitamin daily for pregnancy on 12-OCT-2009 (also reported as September 2009). On 15-OCT-2009, ultrasound was performed with normal result. On 04-NOV-2009, MSAFP was performed and the result was negative. There was no diagnostic test during pregnancy. During pregnancy, the patient experienced cholestasis and profound anemia. On 11-APR-2010 (reported as 04-NOV-2010) the patient was treated with ferrous sulfate 325 mg 3x1day for anemia. On 26-APR-2010, the patient was treated with BENADRYL Q6H for cholestasis. On 29-APR-2010, the patient was treated with ACTIGALL 300mg 2x1day for cholestasis. On 03-MAY-2010 (37 3/7 weeks from LMP), the patient delivered a female infant (weight 7 lbs, length 51cm, Apgar 8+9, head circumference 35.5cm). The infant was reported to be normal. There were no congenital anomalies. During labor/delivery the patient was inadequately treated for a group B strep bacteria. The patient experienced slow weight gain. At the time of the report, the patient recovered from slow weight gain. The baby's experience has been captured in WAES 0910USA02157B1). No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound abdomen
Clinical narrative: Information has been received from a physician assistant, for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female with no pertinent medical history and no drug reactions/allergies who on 01-SEP-2009 was vaccinated with the first dose of GARDASIL (0.5ml, IM, 662229/1497X). There was no concomitant medication. The patient was 3 weeks pregnant when she was vaccinated. The patient had ultrasound to confirm pregnancy. The estimated due date would be on 21-MAY-2010. At the time of reporting the patient was pregnant. Follow up information has been received from the physician assistant concerning a 19 year old female with no significant past medical history, no concurrent medical conditions and no previous pregnancies who on 01-SEP-2009 was vaccinated with a dose of GARDASIL (lot# 662229/1497X) in her left deltoid. Concomitant therapy include prenatal vitamin daily for pregnancy in September 2009. On 15-OCT-2009 ultrasound was performed to confirm the pregnancy and the result was normal. The patient's LMP was reported as 11-AUG-2009 and the EDD was reported as 21-MAY-2010. No adverse event known. At the time of the report the outcome was unknown. Follow up information has been received from a physician's assistant concerning a 19 year old female who had one previous pregnancy and one full term delivery (40 4/7 weeks from LMP). There was no birth defect and no infant complications in previous pregnancy. On 01-SEP-2009, the patient was vaccinated with the first dose of GARDASIL (lot# 662229/1497X). Concomitant therapy include prenatal vitamin daily for pregnancy on 12-OCT-2009 (also reported as September 2009). On 15-OCT-2009, ultrasound was performed with normal result. On 04-NOV-2009, MSAFP was performed and the result was negative. There was no diagnostic test during pregnancy. During pregnancy, the patient experienced cholestasis and profound anemia. On 11-APR-2010 (reported as 04-NOV-2010) the patient was treated with ferrous sulfate 325 mg 3x1day for anemia. On 26-APR-2010, the patient was treated with BENADRYL Q6H for cholestasis. On 29-APR-2010, the patient was treated with ACTIGALL 300mg 2x1day for cholestasis. On 03-MAY-2010 (37 3/7 weeks from LMP), the patient delivered a female infant (weight 7 lbs, length 51cm, Apgar 8+9, head circumference 35.5cm). The infant was reported to be normal. There were no congenital anomalies. During labor/delivery the patient was inadequately treated for a group B strep bacteria. The patient experienced slow weight gain. At the time of the report, the patient recovered from slow weight gain. The baby's experience has been captured in WAES 0910USA02157B1). No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Flank pain, Hypokinesia, Musculoskeletal stiffness, Neck pain
Clinical narrative: Information has been received from a registered nurse concerning her 23 year old daughter with no pertinent medical history and no known allergies who on 24-JUL-2009 was vaccinated with the first dose of GARDASIL (route and LOT# not reported). On 01-OCT-2009 the patient was vaccinated intramuscularly in left arm with the second 0.5mL dose of GARDASIL (LOT# not reported). On 08-OCT-2009 the patient complained to her mother of neck pain and stiffness, which got worse on 09-OCT-2009. On approximately 12-OCT-2009 the patient had back pain and right arm pain but no fever. The patient also had right side pain and she limited movement of the right arm. The reporter stated that her daughter had been treating herself with TYLENOL and ibuprofen (doses and duration not reported). There was no lab performed. The patient had not recovered at this time of the report. Follow-up information has been received from the physician who indicated that the patient has not contacted. The physician without had any complaints. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning her 23 year old daughter with no pertinent medical history and no known allergies who on 24-JUL-2009 was vaccinated with the first dose of GARDASIL (route and LOT# not reported). On 01-OCT-2009 the patient was vaccinated intramuscularly in left arm with the second 0.5mL dose of GARDASIL (LOT# not reported). On 08-OCT-2009 the patient complained to her mother of neck pain and stiffness, which got worse on 09-OCT-2009. On approximately 12-OCT-2009 the patient had back pain and right arm pain but no fever. The patient also had right side pain and she limited movement of the right arm. The reporter stated that her daughter had been treating herself with TYLENOL and ibuprofen (doses and duration not reported). There was no lab performed. The patient had not recovered at this time of the report. Follow-up information has been received from the physician who indicated that the patient has not contacted. The physician without had any complaints. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning an approximately 10 year old female who on 08-SEP-2009 was vaccinated in the left deltoid with the second 0.5 mL dose of GARDASIL and developed swollen lymph nodes that were very painful. The patient had recovered on an unspecified date. The patient sought unspecified medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Biopsy
Clinical narrative: Information has been received from a physician concerning a 14 year old female with obesity, acne, eczema and no drug allergies who in July 2009, was vaccinated with the first and only dose of GARDASIL (route and LOT# not reported). One week after the vaccination, the patient developed anal warts. The biopsy was performed and result pending. The patient was seen by physician and she was not recovered from anal warts. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood human chorionic gonadotropin negative
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 23 year old female with no medical history or concurrent condition who on 26-MAY-2009 and 30-JUL-2009 was vaccinated intramuscularly with her first and second 0.5 mL dose of GARDASIL. There was no concomitant medication. The patient had "missed her last three menstrual periods". The patient performed a home pregnancy test which was negative. At the time of report the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female who was vaccinated with three doses of GARDASIL (lot # not reported). Subsequently the patient developed a rash on her hand after receiving her first and second dose of GARDASIL. The patient also developed a rash on third dose. On the third dose, the rash spread from her hand to her thighs. Unspecified medical attention was sought. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with penicillin allergy who in September 2008 and February 2009 was vaccinated with the first and second doses of GARDASIL (route and lot# not reported). In February 2009, the patient experienced mononucleosis. The patient had not received the third dose of GARDASIL due to being diagnosed with mononucleosis. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Cervix carcinoma, Smear cervix abnormal
Clinical narrative: Information has been received from a doctor's staff concerning a 17 year old female patient who in 2007 was vaccinated intramuscular with the first dose of 0.5 ml GARDASIL. The patient never got her second or third dose. Subsequently a Pap smear done "within the past 2-3 weeks" came back positive for cervical cancer. It was unknown when the cancer started and whether or not it started after she got the first dose of GARDASIL. The outcome of the event was unknown at the time of reporting. The physician stated that the patient was vaccinated with the first dose of GARDASIL (Lot number 660557/0072X) on 11-SEP-2008. The patient did not receive any concomitant vaccinations. On 05-OCT-2009, the patient had a Pap smear which revealed low grade squamous intraepithelial lesion (LSIL). Additionally a medical assistant stated that the patient was seen by a OB/GYN physician on 19-OCT-2009 to discuss the patient's Pap smear results. The patient was scheduled for a colposcopy on 26-OCT-2009. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient fainted. The patient sought additional medical attention after fainting and saw another provider who referred the patient for a CT scan, result not reported. At the time of the report, the patient recovered on an unknown date. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Herpes virus infection, Simplex virus test positive
Clinical narrative: Information has been received from a consumer concerning his friend, a female who was vaccinated with a dose of GARDASIL on an unspecified date. Subsequently the patient tested positive for "herpes virus" test on an unspecified date. At the time of the report, the outcome was unknown. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis, Laboratory test
Clinical narrative: Information has been received from a osteopathy concerning a 15 year old female patient with amoxicillin allergy who on 15-AUG-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. On 15-OCT-2009 the patient was diagnosed with mononucleosis. Physician mentioned the patient was asymptomatic at the time of reporting. Unspecified laboratory tests were performed. The patient had sought medical attention via office visit. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Face injury, Fall, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not provided). Subsequently the patient fainted and fell off the table, scraping her face. The patient sought unspecified medical attention. At the time of the report, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a female who in approximately 2008 ("about 1 year ago") was vaccinated with GARDASIL 0.5 mL. After getting GARDASIL the patient experienced stopped menstruating for a period of time and then went back to normal. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot number not reported). Subsequently, after the vaccination the patient had a red circular rash about the size of a quarter at the injection site which lasted one week. It was unknown if medical attention was sought. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Face injury, Fall, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on 15-OCT-2009 was vaccinated with a first dose of GARDASIL (route and lot # unknown). Concomitant therapy included influenza virus vaccine (unspecified). On 15-OCT-2009 the patient began sweating in the main lobby of the office about 15 minutes after receiving GARDASIL. She fainted a short time later and was carried back to the examination room when she was given oxygen. On the same day, she recovered shortly after the oxygen was administered. Follow up information has been received from a physician concerning the female patient with no illness at time of vaccination and no known drug allergies, who on 15-OCT-2009 was vaccinated with a first dose of GARDASIL, intramuscularly into her right upper extremity, (lot # 663454/0672Y) at 4:45 pm. On the same day a first dose of FLUMIST was administered by nasal route (lot #500695P) at 04:44 pm. It was reported that the patient received the vaccine and then left the exam room and was standing at their checkout desk talking with a physician for approximately 3-4 minutes when she lost consciousness falling toward striking her left cheek on the floor. It was reported that the patient was carried back to exam room and placed on O2 via nasal canula and monitored until fully recovered on 15-OCT-2009. This is one of several reports from the same source. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager concerning a 26 year old female patient with allergic rhinitis and type 1 diabetes mellitus who on 17-SEP-2009 was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number 0053X). Concomitant therapy included insulin, YAZ and montelukast sodium (MSD). The office manager reported that 3-5 minutes after having received the first dose of GARDASIL the patient fainted. After about 30 minutes the patient was fully recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Malaise
Clinical narrative: Information has been received from a consumer concerning her friend who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown) and was complaining of dizziness and "not feeling well". It was unknown if the patient sought medical attention. At the time of this report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who "approximately one month ago" was vaccinated with a dose of GARDASIL (lot# not available). Subsequently, the patient experienced syncope 15 minutes after vaccination. The patient contacted the nurse for medical attention. The patient recovered on the same day the adverse effect occurred. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Nodule, Ultrasound scan
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with asthma and allergic reactions to BIAXIN, AUGMENTIN, atarax, CECLOR, NORBID, erythromycin, penicillin, ADVAIR who on 03-MAY-2009 and 06-JUL-2009 was vaccinated with the first and second doses of GARDASIL. Concomitant therapy included LOESTRIN. On approximately 20-JUL-2009, "2 weeks after the second dose", the patient experienced chest pain, shortness of breath and nodules on her neck. The patient was seen by the physician. X-Ray, EKG and ultrasound were performed with unspecified results. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician who reported that she did not give the patient the GARDASIL. The patient described the symptoms to her after starting therapy with LOESTRIN. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with asthma and allergic reactions to BIAXIN, AUGMENTIN, atarax, CECLOR, NORBID, erythromycin, penicillin, ADVAIR who on 03-MAY-2009 and 06-JUL-2009 was vaccinated with the first and second doses of GARDASIL. Concomitant therapy included LOESTRIN. On approximately 20-JUL-2009, "2 weeks after the second dose", the patient experienced chest pain, shortness of breath and nodules on her neck. The patient was seen by the physician. X-Ray, EKG and ultrasound were performed with unspecified results. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician who reported that she did not give the patient the GARDASIL. The patient described the symptoms to her after starting therapy with LOESTRIN. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female with minocycline allergy, who on 06-OCT-2009 was vaccinated with her second 0.5ml dose of GARDASIL (lot # 663452/0671Y) IM. The same day on 06-OCT-2009 the patient experienced myalgia and nausea, which lasted for 2 days. It was unknown if the patient sought medical attention. The patient recovered on 08-OCT-2009. Follow up information has been received from a nurse practitioner concerning a 22 year old female with minocycline allergy, who on 06-OCT-2009 was vaccinated with her second dose of GARDASIL (lot # 663452/0671Y) IM in the right deltoid. On 08-OCT-2009 (previously reported as 06-OCT-2009) the patient experienced myalgia and nausea for one day. The patient did not seek medical attention. The patient recovered on 09-OCT-2009. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Incorrect dose administered
Clinical narrative: Information has been received from a Registered Pharmacist concerning a female patient who on an unspecified date, was vaccinated with the seventh dose of GARDASIL. On an unknown date, the patient experienced unspecified adverse event and was admitted into hospital. After months into her treatment the nurses were finally able to obtain her vaccination record from her previous school. There was no history of her receiving any GARDASIL recorded. Following her receiving one dose of GARDASIL in the hospital, her mother stated that this was her seventh dose. In obtaining further records from the patient's primary physician, four doses of GARDASIL were documented. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure via breast milk, Dysfunctional uterine bleeding, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a 26 year old female patient, for GARDASIL, a Pregnancy Registry product, concerning herself with allergy to DARVOCET who on 18-SEP-2009 was vaccinated with the first dose of GARDASIL (lot number 0670Y). The patient was pregnant at the time of vaccination. The last menstrual period was not reported. Unspecified medication was sought. On an unspecified date a pregnancy test was performed. The outcome of the patient was not reported. Follow-up information received from a physician concerning the pregnant female patient with history of bladder problems, chickenpox, yeast, kidney problems, mitral valve prolapse, severe headaches and stomach problems and allergy to DARVOCET-N 100 and one normal previous full term delivery at 39 weeks gestation. The last menstrual period (LMP) reported as 28-AUG-2009, estimated conception date 12-SEP-2009, estimated delivery date (EDD) 03-JUN-2010. On 01-OCT-2009, a urine pregnancy test was positive. On 16-OCT-2009, the patient presented for an Obstetrics-Gynecology evaluation with a complaint of dysfunctional uterine bleeding. Since her LMP the patient claimed she had been without significant complaints, and denies the use of alcohol, tobacco and street drug. The patient was currently taking no medication. She was told to start taking prenatal vitamins. On 16-OCT-2009 the physician's plan for the patient was to have a quantitative BHCG test done and progesterone (dose, duration not reported). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 33 month old female patient who on 22-OCT-2009 was inadvertently vaccinated with a dose of GARDASIL instead of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). There was no product confusion but a human error. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a nurse practitioner who reported that she heard that a female patient developed GUILLAIN BARRE SYNDROME after the GARDASIL vaccination. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Upon internal review, GUILLAIN BARRE SYNDROME was determined to be an other important medical event. Attempts to verify the existence of an identifiable patient have been unsuccessful. This is one of several reports received from the same source. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Information has been received from a certified nurse practitioner concerning a 22 year old female patient who on 16-MAR-2010, was vaccinated with the first dose of GARDASIL (Lot#662299/1099Y). The certified nurse practitioner reported that "a while after she received the shot" the patient started having itchy head and started getting hives on her face. The patient sought unspecified medical attention. The nurse told the patient to take BENADRYL and the next day the patient was feeling better and the itchiness and swelling went down a lot. Follow-up information has been received from a nurse practitioner, who reported that the patient developed a localized urticaria on her face and neck within 30 minutes of administration of her first dose of GARDASIL on 16-MAR-2010. The patient was treated with BENADRYL. On 18-MAR-2010, the patient was seen in an urgent care facility and was prescribed prednisone and ranitidine. The hives initially resolved but the patient continued to experience episodes of intermittent hives. On 14-APR-2010, the patient developed widespread urticaria. She was seen again at the urgent care facility on 15-APR-2010, and was prescribed SOLUMEDROL. On 15-APR-2010, the nurse practitioner examined the patient in the office and had added ranitidine therapy. Upon internal review, the administration of SOLUMEDROL for widespread urticaria was considered to be an other important medical event. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Condition aggravated, Dizziness, Tonic clonic movements, Vision blurred
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with a history of previous episodes of dizziness and tonic-clonic movements who on 01-MAR-2010 was intramuscularly vaccinated with GARDASIL.  The registered nurse reported that on 01-MAR-2010 the patient experienced dizziness and tonic-clonic movements.  Then the patient continued to feel dizzy, had blurred vision and was send to the emergency room.  The patient blood pressure was measured (results not provided).  The same day, the patient recovered from dizziness, tonic-clonic movements and blurred vision.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Disorientation, Hyperhidrosis, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with a history of previous episodes of dizziness and tonic-clonic movements who on 01-MAR-2010 was intramuscularly vaccinated with GARDASIL.  The registered nurse reported that on 01-MAR-2010 the patient experienced dizziness and tonic-clonic movements.  Then the patient continued to feel dizzy, had blurred vision and was send to the emergency room.  The patient blood pressure was measured (results not provided).  The same day, the patient recovered from dizziness, tonic-clonic movements and blurred vision.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event, Pyrexia
Clinical narrative: Information has been received from a female consumer concerning "someone she knows" who on an unspecified date was vaccinated with GARDASIL (lot no. not reported). It was reported that the patient had experienced fever as well as other unspecified side effects after receiving GARDASIL. It was also reported that the patient was currently hospitalized. At the time of the report the patient's outcome was not specified. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a consumer concerning a female friend with latex allergy who was vaccinated with a dose of GARDASIL and was hospitalized (name, address and phone number unspecified) for a couple of days.  At the time of the report, the patient's status was unknown.  This is one of several reports received from the same source.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Myalgia, Urticaria
Clinical narrative: Initial and follow up information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the approximately second dose of GARDASIL (lot #, route and site of administration not reported). Subsequently, the patient developed hives, joint pain and muscle aches. The patient was having debilitating problems and now dependent on steroids. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. Hives, joint pain, muscle aches and debilitating problems were considered to be disabling by the reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Malaise
Clinical narrative: Information has been received from a Nurse Practitioner (N.P) who was being questioned by people in her community. There was a female patient "between 13 or 14 year old" who on an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient became very ill and she was not attending school. The Nurse Practitioner stated that none of her patients experienced any adverse events and this was not her patient. The nurse practitioner questioned if there was any GARDASIL lot number that was bad or recalled. The outcome of the patient was not reported. Upon internal review became very ill was considered to be disabling due to the patient was not attending school. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old female patient whowas vaccinated intramuscularly with the first and second dose of GARDASIL (lot#663453/0249Y for both doses) 0.5 mL on 29-SEP-2009 and 11-NOV-2009 respectively. The medical assistant reported that on 29-SEP-2009 the patient developed hives on left arm (time of onset unknown). Then 5 days after second vaccination with of GARDASIL, on 16-NOV-2009, the patient developed hives all over body. It was noted that the patient was in a hot tub prior to reported hives. The patient was treated with BENADRYL and ZYRTEC. On an unspecified date the patient had recovered. The hives was considered an other important medical event by the medical assistant. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Activities of daily living impaired, Asthenia, Back pain, Crying
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 28 year old female patient with no drug reactions/allergies. The medical assistant reported that on 13-NOV-2009 the patient was hospitalized for anemia and had a blood transfusion. The patient was discharged from the hospital on an unknown date. On 16-NOV-2009 the patient went to the emergency room and complained of frequent headaches, nausea, vomiting and blurred vision. It was reported that the patient was not admitted to the hospital. It was also reported by the medical assistant on 17-NOV-2009 that the patient was vaccinated with a first dose of GARDASIL (Lot# 665547/1318Y). There was no concomitant medication and the patient did not receive any concomitant vaccinations when GARDASIL was administered. The physician reported that on 20-NOV-2009 the patient experienced general depression, was just feeling not right, crying, ache and dizziness. It was reported that the patient had dropped out of school because of what she was experiencing and had gone to the emergency room five times for the symptoms she was having. The physician also stated the patient was still experiencing the depression and had been put on Alprazolam (manufacturer unspecified). The medical assistant reported that on 26-NOV-2009 the patient went to the ER and complained of abdominal pain. The patient was not admitted to the hospital. On 01-DEC-2009 the patient had another physician's visit. The patient complained of abdominal pain, back pain, vomiting and headache. On 11-DEC-2009 the patient was seen by the physician. On 14-DEC-2009 the patient was seen by the physician and complained of headache, back pain and swollen glands. The patient was referred to an ENT specialist (name not reported). On 10-FEB-2010, the patient was seen by the physician. The patient complained of muscle aches, decreased ability to interact with other, decreased ability to concentrate, decreased energy and had no appetite. The physician advised the patient to have a Psychology evaluation. An ultrasound was ordered to rule out thyroid nodules and a TSH laboratory blood test was ordered. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Depression, Disturbance in attention, Dizziness, Feeling abnormal
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 28 year old female patient with no drug reactions/allergies. The medical assistant reported that on 13-NOV-2009 the patient was hospitalized for anemia and had a blood transfusion. The patient was discharged from the hospital on an unknown date. On 16-NOV-2009 the patient went to the emergency room and complained of frequent headaches, nausea, vomiting and blurred vision. It was reported that the patient was not admitted to the hospital. It was also reported by the medical assistant on 17-NOV-2009 that the patient was vaccinated with a first dose of GARDASIL (Lot# 665547/1318Y). There was no concomitant medication and the patient did not receive any concomitant vaccinations when GARDASIL was administered. The physician reported that on 20-NOV-2009 the patient experienced general depression, was just feeling not right, crying, ache and dizziness. It was reported that the patient had dropped out of school because of what she was experiencing and had gone to the emergency room five times for the symptoms she was having. The physician also stated the patient was still experiencing the depression and had been put on Alprazolam (manufacturer unspecified). The medical assistant reported that on 26-NOV-2009 the patient went to the ER and complained of abdominal pain. The patient was not admitted to the hospital. On 01-DEC-2009 the patient had another physician's visit. The patient complained of abdominal pain, back pain, vomiting and headache. On 11-DEC-2009 the patient was seen by the physician. On 14-DEC-2009 the patient was seen by the physician and complained of headache, back pain and swollen glands. The patient was referred to an ENT specialist (name not reported). On 10-FEB-2010, the patient was seen by the physician. The patient complained of muscle aches, decreased ability to interact with other, decreased ability to concentrate, decreased energy and had no appetite. The physician advised the patient to have a Psychology evaluation. An ultrasound was ordered to rule out thyroid nodules and a TSH laboratory blood test was ordered. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Lymphadenopathy, Myalgia, Pain, Social avoidant behaviour
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 28 year old female patient with no drug reactions/allergies. The medical assistant reported that on 13-NOV-2009 the patient was hospitalized for anemia and had a blood transfusion. The patient was discharged from the hospital on an unknown date. On 16-NOV-2009 the patient went to the emergency room and complained of frequent headaches, nausea, vomiting and blurred vision. It was reported that the patient was not admitted to the hospital. It was also reported by the medical assistant on 17-NOV-2009 that the patient was vaccinated with a first dose of GARDASIL (Lot# 665547/1318Y). There was no concomitant medication and the patient did not receive any concomitant vaccinations when GARDASIL was administered. The physician reported that on 20-NOV-2009 the patient experienced general depression, was just feeling not right, crying, ache and dizziness. It was reported that the patient had dropped out of school because of what she was experiencing and had gone to the emergency room five times for the symptoms she was having. The physician also stated the patient was still experiencing the depression and had been put on Alprazolam (manufacturer unspecified). The medical assistant reported that on 26-NOV-2009 the patient went to the ER and complained of abdominal pain. The patient was not admitted to the hospital. On 01-DEC-2009 the patient had another physician's visit. The patient complained of abdominal pain, back pain, vomiting and headache. On 11-DEC-2009 the patient was seen by the physician. On 14-DEC-2009 the patient was seen by the physician and complained of headache, back pain and swollen glands. The patient was referred to an ENT specialist (name not reported). On 10-FEB-2010, the patient was seen by the physician. The patient complained of muscle aches, decreased ability to interact with other, decreased ability to concentrate, decreased energy and had no appetite. The physician advised the patient to have a Psychology evaluation. An ultrasound was ordered to rule out thyroid nodules and a TSH laboratory blood test was ordered. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.