chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Local swelling, Neck pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who on an unspecified date, was vaccinated with the first 0.5ml dose of GARDASIL (lot # not reported).  Subsequently, the patient developed swelling at the injection site, pain and swelling from elbow to neck.  It was reported that the patient developed swelling at the injection site, pain and swelling from elbow to neck after getting each dose of GARDASIL.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning an 18 year old female patient who on 02-MAR-2010 was vaccinated with the first 0.5ml dose of GARADSIL (lot#662304/1013Y). On 02-MAR-2010, "right after getting the vaccine", the patient developed bruise at the injection site. It was reported that in the first week after she had a bruise at the injection site. The bruise was gone however the patient was still experiencing pain in the arm where the vaccine was given. Unspecified medical attention was sought. The physician told the patient to take MOTRIN and it worked, however as soon as MOTRIN wore off she experienced pain again. There were no laboratory diagnostics studies performed. Follow up information has been received from the registered nurse concerning the 18 year old female student with no pre-existing allergies and no other relevant medical histories who on 02-MAR-2010 was vaccinated with the first 0.5ml dose of GARDASIL (lot#662304/1013Y) into the left deltoid. On 02-MAR-2010, the patient was reported to have continued soreness at site (left deltoid) since vaccination on 02-MAR-2010. The patient had bruising for a week after vaccine was given. At the time of this report, the patient had recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female patient who on 04-OCT-2007 was vaccinated with the first 0.5 ml dose of GARDASIL. On 05-DEC-2007 and 06-OCT-2008, the patient was vaccinated with the second and third dose of GARDASIL respectively. It was reported that the patient had high risk PAP smear after getting all three doses of GARDASIL. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has received from a physician via medical records concerning a 17 year old female student who on 12-APR-2007 was vaccinated with the first dose of GARDASIL IM, (Lot number: 657006/0188U), on 28-JUN-2007, received her second dose of GARDASIL IM, (Lot number: 657736/0389U) and on 31-OCT-2007, her third dose of GARDASIL IM, (Lot number: 659437/1266U). On the same day the patient received a dose of FLUZONE I.M. (Lot number: U2500AA). There was no concomitant medication reported. On 22-APR-2010 the patient had a combined HPV/gynecology report which showed low grade squamous intraepithelial lesion (LSIL), encompassing mild dysplasia (CIN I) and/or associated changes. At the time of reporting the patient present status was unknown. The patient's immunization record included Hib (manufacturer unspecified) 05-Oct-1992, 08-DEC-1992, 19-FEB-1993 and 13-OCT-1993. DTaP (manufacturer unspecified) 05-OCT-1992, 08-DEC-1992, 19-FEB-1993, 21-JAN-1994 and 29-Aug 1997. HepB 21-JAN-1994, 24-AUG-1994 and 28-OCT-1994. MMR II 05-OCT-1992, 08-DEC-1992, 19-FEB-1993 and 13-OCT-1993. IPOL 05-OCT-1992, 08-DEC-1992, 21-JAN-1994 and 29-AUG-1997. On 27-AUG-2004 patient received a dose of tetanus toxoid and tuberculin purified protein derivative. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Injection site cyst, X-ray
Clinical narrative: Information has been received from a medical assistant at a physician's office concerning a female patient who on an unspecified date was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number not reported). Subsequently the patient experienced a knot/cyst at the injection site. The physician removed it surgically. X-ray and biopsy were performed (result not provided). At the time of the report, the patient was recovering. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inappropriate schedule of drug administration, Smear cervix abnormal
Clinical narrative: Information has been received from a pharmacist concerning his approximately 17 year old daughter with no known drug reactions or allergies and that smokes cigarettes who on 24-OCT-2007 was intramuscularly vaccinated with the first dose of GARDASIL and on 29-SEP-2009, received her second dose of GARDASIL. Concomitant therapy included unspecified oral contraceptive. The pharmacist reported that in June or July 2009, his daughter had an abnormal PAP test, the result was positive for GARDASIL. It was reported that the abnormal PAP test was before the patient received the second dose of the vaccine. The patient sought medical attention by a physician office visit. At the time of the report, the patient outcome was unspecified. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. This is one of several cases reported by the same source.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a nurse in office concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). The patient had syncopal events after vaccination and hit her head while walking back to the reception desk. It was unknown if medical attention was sought. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician assistant concerning a female patient "between the age of 17 and 21" years, who on an unspecified date was vaccinated with the third dose of GARDASIL. The physician assistant reported that on an unspecified date, the patient tested positive for HPV after receiving the three doses of GARDASIL. The patient sought unspecified medical attention. It was noted that the patient had unprotected sex. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Cervical dysplasia, Drug exposure during pregnancy, Smear cervix abnormal, Ultrasound scan normal
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient who on 05-NOV-2009 was vaccinated with the first dose of GARDASIL (lot # 663453/0249Y). Concomitant therapy included ADDERALL TABLETS and prenatal vitamins (unspecified). Subsequently the patient was found to be pregnant, with last menstrual period (LMP) 26-OCT-2009, and estimated delivery date (EDD) 20-AUG-2010. On 05-NOV-2009 the patient had Pap smear performed which showed abnormal result of low grade squamous intraepithelial lesion (LGSIL). On 29-DEC-2009, ultrasound was performed for dating scan which showed IVP seen consistent with 6 week and 4 day pregnancy. On 15-MAR-2010, routing pregnancy lab alpha-fetoprotein test (AFP) was performed with normal result. At the time of reporting, the  outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Injection site mass
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female patient with no pertinent medical history and no drug reactions/allergies who on 19-MAR-2010 was vaccinated on the buttocks with the second dose of GARDASIL. On 25-MAR-2010 the patient developed short of breath and lump at the injection site. The patient sought unknown medical attention. There were no lab diagnostic tests performed. At the time of report the patient's status was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician's assistant concerning an 18 to 25 year old female patient who in 2007 was vaccinated the first 0.5 ml dose of with GARDASIL in 0, 2, 6 months. In 2008 she completed the series of GARDASIL injections. In 2008 subsequently the patient had problems with "ASCUTS" and tested positive for HPV. It was unknown if the patient sought medical attention. At the time of report the patient's status was unknown. Follow up information has been received from the physician's assistant (PA) concerning the female patient who had a normal PAP in fall of 2009 (in approximately September 2009). The patient received the first, second and third doses of GARDASIL from 2009 to 2010 (conflicting dates from initial information). The patient had her next PAP test in the "fall" of 2010 which showed ASCUS (+) HPV. There were no new partners but she was sexually active. She likely already had HPV and it was not detected on the original PAP or she contacted it in the middle of the vaccination course. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a medical assistant concerning a 10 year old patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot# not reported). It was reported that the patient developed headache. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Microbiology test abnormal, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on an unknown date was vaccinated with a 0.5 ml third dose of GARDASIL. Subsequently the patient had abnormal PAP (Papanicolaou test) and tested positive for HPV (human papillomavirus). The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. The medical assistant contacted during telephone follow-up stated that she did not remember the patient's name or any other patient identifier. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse in office concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). The patient had syncopal events after vaccination. It was unknown if medical attention was sought. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal disorder
Clinical narrative: Information has been received from a physician concerning a female relative who "3 years ago" (in March 2007), was vaccinated with a dose of GARDASIL. Subsequently the patient experienced a musculoskeletal issue after getting GARDASIL (in March 2007). At the time of the report the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: Information has been received from an 18 year old female via internet, who on an unspecified date was vaccinated with GARDASIL (lot number, route and site not reported). Subsequently the patient experienced autoimmune disorder. At the time of the report, the outcome was not reported. It was unknown if the patient sought medical attention. Attempts to verify the existence of an identifiable patient have been unsuccessful. This is one of several reports received from the same source.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on approximately 19-JAN-2010 ("2 months ago") was vaccinated with the first dose of GARDASIL. On 19-MAR-2010, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL. In approximately January 2009 ("after the first dose"), the patient experienced missed two menstrual cycles. No lab diagnostics studies were performed. At the time of reporting, the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Vaccination complication
Clinical narrative: Information has been received from a 23 year old female patient who "just" (approximately in March 2010) was vaccinated with the third dose of GARDASIL (lot number not reported). The patient stated that on the final injection she had a reaction and her arm became swollen. The patient did not state that she received any medical attention or if the reaction continued. Follow-up information was received from a registered nurse (R.N.) via medical records who reported that on 14-AUG-209, 29-OCT-2009 and 01-MAR-2010, the female chef with no known drug allergies was administered the first, second and third doses of GARDASIL IM in the right arm, respectively (Lot # of 1st and 2nd dose: 661846/1312X, expiration date 11-MAR-2011; Lot # of the 3rd dose: 662529/1317Y, expiration date: 30-MAY-2011). Secondary suspect therapy included DEPO-PROVERA 150 mg administered IM in the left deltoid on 14-AUG-2009, 29-OCT-2009 (Lot #0A2BX, expiration date March 2012) and 19-JAN-2010 (Lot #0A3SA, expiration date May 2012), respectively. It was reported that the patient did not have any problems with the two shots of DEPO-PROVERA on 29-OCT-2009 and 19-JAN-2010 and tolerated well. On 30-OCT-2009 the patient was seen in the department (also reported as patient did not require emergency room/doctor visit) with a complaint of pain at injection site from DEPO-PROVERA. Patient was able to move arm and grip. It was reported that the patient did not typically have pain with the shot. Physical examination showed patient had no redness, and the full range of motion was in the left arm, equal grip bilaterally. The assessment was pain to injection site. Patient was offered alternate water/ice to the affected area, and encouraged arm movement to disperse medications. Therapy with MOTRIN as needed was prescribed and patient was to be followed up if no improvement. The outcome of the events was not provided. Follow-up information was received from the R.N. who reported this was a GARDASIL adverse event from 29-OCT-2009. The patient complained that her left arm was sore but GARDASIL was given in the right arm. DEPO-PROVERA was given in the left arm. The nurse further reported that the patient had not been seen at the office since that time and she had no other updates on this patient. She might contact the patient and would call back if she had any other follow-up. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis, Injection site mass, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a Registered Nurse and a physician concerning a 15 year old female patient who on 17-MAR-2010 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL. Subsequently the patient developed a rash on her body. The rash was itchy and red. On an unspecified date, the patient recovered. The patient sought medical attention (office visit). Follow up information has been received from a Registered Nurse who reported that the 15 year old female patient with asthma and no illness at the time of vaccination, was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (lot # 662529/1317Y) on 17-MAR-2010 at 18:00. Concomitant therapy included ALLEGRA-D, montelukast sodium (MSD), NASACORT and albuterol. It was stated that 10 days after administration, on 21-MAR-2010, the patient reported by a phone conversation that shortly after GARDASIL administration, on approximately 18-MAR-2010, she developed a pinpoint red "heat rash" over trunk. On 29-MAR-2010, on exam, rash was resolving. The patient was diagnosed with dermatitis unspecified. The patient also described a "lump" at the site, which was presumed to be a local reaction which resolved on an unspecified date. No laboratory diagnostic studies were performed. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from an article on the internet, from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of GARDASIL. The mother stated that her daughter was always healthy before the vaccination and was so ill now. This is one of several cases from the same source. Attempts to verify the existence of an identifiable patient have been unsuccessful.
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Skin papilloma
Clinical narrative: Information has been received from an article on the internet, from a consumer concerning her daughter who was vaccinated with a dose of GARDASIL. The mother stated that her daughter was now sick after the GARDASIL vaccination and had warts on her hands and feet. This is one of several cases from the same source. Attempts to verify the existence of an identifiable patient have been unsuccessful.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from an article on the internet reported by a mother, who's daughter, two years ago, was vaccinated with GARDASIL. Subsequently, the patient experienced an "irregular Pap" 2 years after the vaccine series. Medical attention was unspecified. At the time of the report, the patient's status was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Depressed mood, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health care worker concerning a female who on an unspecified date was vaccinated with 0.5 ml a first dose of GARDASIL (route and lot number not reported). In the "past two weeks" (approximately on 16-MAR-2010) was vaccinated with 0.5 ml a second dose of GARDASIL (route and lot number not reported). The health care worker stated that "the patient developed flu like symptoms and she felt down and out after received her first and second dose of GARDASIL" "with in the same date of receiving the vaccine" (approximately on 16-MAR-2010). At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a female patient with a history of sexually active before vaccination who in 2008 was vaccinated with her series of GARDASIL (exact dates unspecified). A recent Pap test (in 2010) was abnormal and tested positive for a high risk human papillomavirus (HPV) type. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Follow-up information has been received from a medical assistant in the physician's office concerning the approximately 20 year old female patient. The medical assistant had no information on GARDASIL as it was administered at another office. She was not sure if the series was completed. The patient was "currently" pregnant (not reported initially) and the patient has not received a vaccine recently. The medical assistant confirmed that there was an abnormal PAP. There were no details of pregnancy provided. The outcome of the patient was not reported. No further information is available. This is a consolidation of two reports concerning the same patient.
Sex: F
Vaccine: HPV4
Symptoms: Diabetes mellitus, Polycystic ovaries
Clinical narrative: Information has been received from an office manager concerning her daughter who on unspecified dates was vaccinated with all three doses (Lot# not provided) of GARDASIL. After getting all three doses of GARDASIL, the patient developed polycystic ovarian syndrome ("PCOS") and diabetes. The patient sought unspecified medical attention. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Joint swelling
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the second 0.5ml dose of GARDASIL, IM. "9 days after the vaccination, the patient experienced joint pain, swelling of the knees, fatigue, headache and a blotchy bright red face. The events lasted for approximately 3 to 4 weeks". The patient did not seek medical attention. At the time of the report, the patient recovered. Follow up information received from a physician concerning a 14 (previously reported as 15 year old) year old female with Coeliac disease and penicillin allergy, who on 15-OCT-2009 at 11:30 am was vaccinated with the second dose of GARDASIL (IM, lot # 663452/0671Y) in the right arm. Subsequently (on 24-OCT-2009, 9 day after the vaccination) the patient experienced joint pain, swelling of the knees, fatigue, headache and a blotchy bright red face following the second dose of vaccination. All pertinent work up was done through the patient's Gastrointestinal (GI) & rheumatology doctors. The reporter did not have notes at labs or imaging studies to back up the health concerns. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash macular
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the second 0.5ml dose of GARDASIL, IM. "9 days after the vaccination, the patient experienced joint pain, swelling of the knees, fatigue, headache and a blotchy bright red face. The events lasted for approximately 3 to 4 weeks". The patient did not seek medical attention. At the time of the report, the patient recovered. Follow up information received from a physician concerning a 14 (previously reported as 15 year old) year old female with Coeliac disease and penicillin allergy, who on 15-OCT-2009 at 11:30 am was vaccinated with the second dose of GARDASIL (IM, lot # 663452/0671Y) in the right arm. Subsequently (on 24-OCT-2009, 9 day after the vaccination) the patient experienced joint pain, swelling of the knees, fatigue, headache and a blotchy bright red face following the second dose of vaccination. All pertinent work up was done through the patient's Gastrointestinal (GI) & rheumatology doctors. The reporter did not have notes at labs or imaging studies to back up the health concerns. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site paraesthesia, Joint range of motion decreased, Neck pain
Clinical narrative: Information has been received from an Advanced Registered Nurse Practitioner concerning a 15 year old female patient with drug reactions/allergies to amoxicillin and sulfa medicines, who on 18-DEC-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 662304/1013Y) and on 12-MAR-2010, the patient was vaccinated with the second dose of GARDASIL (lot number 665266/1378Y). There was no concomitant medication. On 12-MAR-2010 the patient experienced extreme left neck pain with tricep tingling at the injection site of her left arm. The patient also had limited range of motion of her neck and left arm. The patient was taking ibuprofen for the discomfort. On 16-MAR-2010, the patient visited the doctor. The patient had no adverse symptoms after the first dose of GARDASIL. At the time of the report, the patient had not recovered. No laboratory diagnostics studies were performed. Follow up information has been received from a Nurse Practitioner who stated that the patient did not receive any concomitant vaccinations when GARDASIL vaccinations were administered. The Nurse Practitioner spoke to the patient's mother on 19-MAR-2010 and the patient was doing better. The patient had an increase in motion in her neck and arm. The patient was treated with "heat and ibuprofen". Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 14 year old female who approximately "4 years ago" (in 2006) was vaccinated with all three doses of GARDASIL (dates, routes, sites of injection and lot numbers not reported). The physician reported that the patient had a Papanicolaou (PAP) test and the result came in as Human Papillomavirus (HPV) positive but HPV type was unknown (date unspecified). At the time of the report the outcome of the patient was recovered (date not reported). The patient sought unspecified medical attention. Follow up has been received from a nurse practitioner who reported that her patient is 14 year old now and she received all 3 doses of GARDASIL when she was 11 year old. The sexually active patient had an abnormal Papanicolaou (PAP) test (Atypical Squamous Cells of Undetermined Significance (ASC-US) (date unspecified). The colposcopy was done (date unspecified). And the result of the biopsy was pending. In the follow up information the physician had a question that if company has information on the breakthrough disease after vaccinating 11 year old patient with the GARDASIL. The physician would plan to run the Cervista test (Hologic) to determine what HPV type may be causing the Atypical Squamous Cells of Undetermined Significance (ASC-US). Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 24 year old female patient with no medical history, drug reactions or allergies reported, who on 10-NOV-2009 was vaccinated with a 0.5 mL first dose of GARDASIL intramuscular route (lot # 663454/0672Y) after a negative urine pregnancy test. Concomitant therapy included birth control pills. The nurse stated that on 24-FEB-2010, the patient returned to the office for her second dose of GARDASIL but a urine pregnancy test was positive and the second dose was not given. The nurse also reported that on 24-FEB-2010, some bleeding was noted. A beta quant blood test was performed with unspecified results. The patient's last menstrual period was approximately on 17-JAN-2010 and the delivery date is 24-OCT-2010. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Follow up information has been received from the physician who reported that the patient was not under her care and she had no information. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on an unknown date was vaccinated with a 0.5 ml third dose of GARDASIL. Subsequently the patient had abnormal PAP (Papanicolaou test) and tested positive for HPV (human papillomavirus). The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. The medical assistant contacted during telephone follow-up stated that she did not remember the patient's name or any other patient identifier. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in 2003 was vaccinated with the first dose of GARDASIL. It was reported that the patient did not remember if she ever received her second or third dose of GARDASIL. The nurse reported that the patient memory was not reliable. Additional it was reported that the patient very recently had unprotected sex and has not had a period for one month. Nurse stated that the patient very recently had unprotected sex and had not had a period for one month. A pregnancy test was performed and the result was negative. The nurse stated that due to unprotected sex and the patient could still had the possibility of being pregnant. The nurse reported that the patient had no apparent adverse effect noted due to the possibility of not completing the series. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injury
Clinical narrative: Information has been received from a consumer via an internet newspaper concerning her daughter who an unspecified date was vaccinated with a dose of GARDASIL. It was reported that the patient had been horrifically injured (unspecified injuries) by the GARDASIL. At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Throat tightness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female patient with no pertinent medical history and no drug reactions/allergies who on 27-JUL-2009 was vaccinated with the first 0.5mL dose of GARDASIL (lot# 661953/1130X) IM. Secondary suspect vaccination on the same day included a dose of varicella virus vaccine live (duration and dose not reported). Other concomitant therapies included hormonal contraceptives (unspecified) and RETIN-A topical cream. On 27-JUL-2009 the patient fainted after receiving her first dose of vaccination. On the same day, the patient recovered from fainting. On 08-OCT-2009 the patient was vaccinated with the second 0.5mL dose of GARDASIL (lot# 663453/0249Y) IM. The patient's "throat felts tight" while she was still in the office after receiving her second dose of vaccination. No laboratory diagnostic studies were performed. The patient was treated with BENADRYL while she was in the physician's office after dose number two. On the same day the patient recovered from throat tightness. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a health professional (Licensed visiting nurse) concerning a 27 year old female patient who was administered 0.5 cc of GARASIL of unknown strength as preventive. There is no relevant medical history. Relevant past drug history is unknown. There are no relevant concomitant medications. This nurse reported that this patient got her second dose of GARDASIL on 01-OCT-2009. The patient woke up with redness and itching on 12-FEB-2010 and the red and itchy area was expanding due to which she contacted the doctor's office. It is unknown what treatment was given. There were no relevant laboratory test performed. As of 24-FEB-2010 this consumer is not on GARDASIL and the status of her events is unknown.
Sex: F
Vaccine: HPV4
Symptoms: Acne, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified  dates were vaccinated with two doses of GARDASIL (LOT#s not reported). After the patient receiving the dose 1 her acne flared up and then later subsided. After she receiving her dose 2 her acne flared up again. The patient was seen by physician and the physician has prescribed ACCUTANE. At this time of reporting, the recurrent acne flared up's outcome was unknown. The physician did not want this reported. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Hypotension, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female patient with no known allergies who on 01-MAR-2010 was vaccinated in the left deltoid with the first 0.5 ml dose of GARDASIL (lot number 663558/0819Y). Concomitant therapy include birth control pills (unspecified). Immediately post vaccination, the patient experienced syncope event. The patient turned pale, and was told to put her head down between her knees. Then the patient seat up rigid and her eyes were out of it. The patient was laid down on the floor and monitored. Her heart rate was 60, blood sugar 118, and her blood pressure "was very low", but unspecified. The patient was observed and fully recovered in the office. The nurse practitioner stated that the patient has had similar episodes in school where she passed out due to any blood or gory type of information or exposure. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with a history of syncope who on approximately 19-JAN-2010, "about 2 months ago" was vaccinated with the first dose of GARDASIL (0.5 ml). Within 20 minutes the patient experienced syncope. The patient recovered soon after. No further information is available.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a currently 28 year old female patient with history of "abnormal PAP smear" who at age of 26 year old completed her GARDASIL series. It was reported that the now 28 year old patient, returned to the office for her 6-8 post partum check up and her "PAP smear results" were abnormal. It was unknown if the patient received any treatment or if her PAP smear results ever returned to normal after the first abnormal result from years ago. At the time of the report the patient's status was not specified. The patient sought medical attention by an office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date, was vaccinated with the second dose of GARDASIL (lot# not reported). Subsequently, the patient called the nurse and left message on nurses line which reported that she had an allergic reaction to her second dose of GARDASIL and she was inquiring if she should get her third dose. It was reported that the patient did not have a reaction on the first dose of GARDASIL. No medical attention was sought. At the time of this report, the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who completed her full course of GARDASIL. Subsequently the patient had an "abnormal PAP smear". The patient was believed to be HPV naive at the time of vaccination. The patient had sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who was vaccinated IM with 0.5 ml a dose of GARDASIL (dose, date and lot number not reported). The nurse practitioner reported that the patient received a dose of GARDASIL and developed a rash on her stomach. The nurse practitioner did not think it was caused by GARDASIL. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention (if office visit or a phone call). No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Joint swelling, Laboratory test normal, No reaction on previous exposure to drug, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 15 year old female, who on 28-JUL-2009, received her first dose of GARDASIL (route not provided) (lot number 662404/0312Y). On 28-SEP-2009, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot number 663558/0819Y). The patient did not experience any adverse event after first dose. In approximately November 2009, 2-3 months later after getting the second dose, the patient experienced severe joint pain and knee swelling. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered from severe joint pain and knee swelling. Follow up information has been received from a physician and a registered nurse who indicated that the patient was a female student with sulfur and codeine allergies and a medical history of Streptococcal infection; the patient's mother reported that her daughter has not had a Streptococcal infection in years. On 28-SEP-2009 at 10:00 the patient was vaccinated intramuscularly into her left arm with as second dose of GARDASIL (lot number 663558/0819Y). There was no illness at the time of vaccination. In December 2009 the patient developed bilateral knee swelling and joint pain in knees, ankles, elbows and fingers. On 09-FEB-2010 the patient had lab studies performed her serum antistreptolysin O antigen test was 315 IU/mL (normal: 0-200). The patient also had an autoimmune work up which came back negative, the patient was cleared by rheumatology. On 16-FEB-2010 the patient's mother reported that the patient had increased swelling in her knees. She also had hip pain and arm swelling. The patient was prescribed AMOXIL 875 mg, 1 tab BID x 10 days. At the time of this report the patient had not recovered. Follow up information has been received from a nurse who reported that the patient had not recovered as previously noted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcus test positive
Clinical narrative: Information has been received from a physician concerning a 15 year old female, who on 28-JUL-2009, received her first dose of GARDASIL (route not provided) (lot number 662404/0312Y). On 28-SEP-2009, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (lot number 663558/0819Y). The patient did not experience any adverse event after first dose. In approximately November 2009, 2-3 months later after getting the second dose, the patient experienced severe joint pain and knee swelling. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered from severe joint pain and knee swelling. Follow up information has been received from a physician and a registered nurse who indicated that the patient was a female student with sulfur and codeine allergies and a medical history of Streptococcal infection; the patient's mother reported that her daughter has not had a Streptococcal infection in years. On 28-SEP-2009 at 10:00 the patient was vaccinated intramuscularly into her left arm with as second dose of GARDASIL (lot number 663558/0819Y). There was no illness at the time of vaccination. In December 2009 the patient developed bilateral knee swelling and joint pain in knees, ankles, elbows and fingers. On 09-FEB-2010 the patient had lab studies performed her serum antistreptolysin O antigen test was 315 IU/mL (normal: 0-200). The patient also had an autoimmune work up which came back negative, the patient was cleared by rheumatology. On 16-FEB-2010 the patient's mother reported that the patient had increased swelling in her knees. She also had hip pain and arm swelling. The patient was prescribed AMOXIL 875 mg, 1 tab BID x 10 days. At the time of this report the patient had not recovered. Follow up information has been received from a nurse who reported that the patient had not recovered as previously noted. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 27 year old female consumer with no medical history or allergies who on 13-AUG-2009 was vaccinated IM, 0.5 ml, with the first dose of GARDASIL injection (lot # 661841/0653X), the second dose of GARDASIL injection (lot # 661841/0653X) on 29-OCT-2009, and the third dose of GARDASIL injection (lot # 661841/0653X) given in left deltoid on 25-FEB-2010. Concomitant therapy included ESTROSTEP. On 26-FEB-2010 the consumer had pain in her arms when typing and felt swelling under her left arm. There were no laboratory studies performed. The consumer called the doctor on 01-MAR-2010 to report this. The area was still swollen but getting better and the consumer did not want to be seen by the doctor. The consumer had no adverse symptoms after the first and second dose of GARDASIL. Follow-up information has been received from a certified medical assistance concerning the 27 year old female manager with no medical history or allergies or illness at time of vaccination who on 25-FEB-2010 at 09:45 was vaccinated IM with the third dose of GARDASIL (lot # 661841/0653X) in her left deltoid. The patient called the office 4 days after receiving vaccine complaining of swelling and pain under arm that started the day after the vaccine on 26-FEB-2010, but that was already much better. There were no laboratory studies that were known to this office. The patient declined visiting doctor of medicine (MD). On 05-MAR-2010, the patient "felt great" and recovered. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Injection site erythema, Neck pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history and with penicillin allergy who on 03-AUG-2009 was vaccinated with the first 0.5ml dose of GARDASIL (lot number not reported), on 08-OCT-2009 the patient was vaccinated with the second 0.5ml dose of GARDASIL (lot number not reported), and on 19-MAR-2010 the patient was vaccinated with the third 0.5ml dose of GARDASIL (lot number 665768/1354Y), via intramuscular. Concomitant therapy included birth control pills (unspecified). On 21-MAR-2010 the patient developed arthritic type pain on the arm opposite of injection site and spread up to her neck. A nurse reported that the patient experienced joint pain after her third dose of GARDASIL. No lab diagnostics studies were performed. The patient's experiences persisted. On 22-MAR-2010, the patient sought unspecified medication via a telephone call. Follow-up information was received from a physician. It was reported that the female (student) had no previous exposure to this or related drug and no problems were noted with the first two dose GARDASIL immunizations. On 20-MAR-2010, the patient experienced local erythema at injection site. After 2 days, on 22-MAR-2010 the patient recovered from local erythema at injection site. On 22-MAR-2010, the patient experienced arthralgias in right shoulder, wrist and elbow. After 7 days, on 28-MAR-2010, the patient recovered from arthralgias in right shoulder, wrist and elbow. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 21 years old female with a history of cold sores, sulfonamide allergy and allergic reaction to CIPRO who on 19-OCT-2009 and 19-NOV-2009 was vaccinated intramuscularly with the first 0.5 mL and second 0.5 mL dose of GARDASIL (dose 1 LOT# 659054/0311Y and dose 2 LOT# 659054/0311Y), respectively. Concomitant therapy included ADDERALL TABLETS, YAZ and cyclobenzaprine HCl (MSD) and TWINRIX (with the second dose of GARDASIL). The physician reported that the patient experienced cold sores on her mouth each time after receiving GARDASIL doses. Unspecified medical attention was sought. There was no lab diagnostics study performed. The patient recovered approximately 1 and 1/2 weeks after getting cold sores. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood test normal, C-reactive protein normal, Chest pain, Condition aggravated
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: Dizziness, Dyspnoea, Electrocardiogram normal, Electroencephalogram normal, Eye movement disorder
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.