chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who on 25-APR-2011 was vaccinated with the first dose of GARDASIL (Lot number not reported) and on the same day the patient experienced headache, nausea and blurry vision. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Follow up information has been received from a licensed practical nurse reporting that the 19 year old female patient with drug allergy to BETADINE, codeine and nonsteroidal anti-inflammatory drug (NSAID's) and no illness at time of vaccination, on 25-APR-2011 was vaccinated in her left deltoid, with the first dose of GARDASIL (Lot number 0057AA) at 10:00 a.m. and on the same day at 13:30 (also reported around 12:39 p.m) the patient experienced headache, nausea and blurry vision. No lab diagnostics studies were performed. It was reported that on an unspecified date the patient recovered. No further information is available.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a medical assistant concerning a 31 year old female patient who on 25-FEB-2010, 04-MAY-2010 and 10-SEP-2010 was vaccinated with the first, second and third dose of GARDASIL (third dose lot# 666596/0414Z, expiration: October 2012) respectively (dose, strength and therapy route were unspecified). The medical assistant reported that on 07-FEB-2011 the patient who was performed the lab diagnostics with Pap test and HPV screening tested positive for high risk HPV on a routine HPV DNA screening test performed. At time of report, the patient's status was unknown. The patient did not seek medical attention. Follow up information has been received from a health professional who said no reactions noted so far. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Fatigue, Oropharyngeal pain, Pain in extremity, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning an approximately 46 year old (also reported as "early forties") female friend with iodine allergy and no medical history who on unknown date was accidentally vaccinated with a dose of GARDASIL (lot number, dose and site of administration not reported). Concomitant therapy included something for cholesterol. The patient stated that she went to the health department to get HepA and HepB to go out of country. The patient asked the nurses three times if they had the correct vaccines and they said not to worry. The next day after the vaccination, the patient became extremely tired, her legs were killing her and she had sore throat. The patient was so tired and she not stay in class. One day after the vaccination, health department called to tell her what they had done. The nurse was in panic and asked her to the office to get HepA (manufacturer unknown) and HepB (manufacturer unknown) that she was supposed to received. When the patient returned to get the vaccines, no treatment was given for the symptoms. It was unspecified if the patient sought medical attention. At the time of the report, the patient had not recovered and getting worse. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning that a mother reported her 15 year old daughter with acne who on 21-JAN-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot # 666163/0664Z, expired date 18-SEP-2012) in her right deltoid. On 28-MAR-2011 the patient was vaccinated with the second dose of GARDASIL (therapy route not provided, lot # 667194/1271Z, expired date 11-DEC-2011) in her right deltoid. Concomitant therapy included EPIDUO. 2 days after receiving the second dose of GARDASIL, on 30-MAR-2011, the patient developed an itchy rash with hives "from her head to her toes". There was no reaction reported after the patient received her first dose of GARDASIL. It was reported that the mother did not plan to bring the child into the office for an assessment. No treatment was given for this adverse event. No lab diagnostics studies were performed. Patient sought medical attention via calling to the office. At the time of reporting, the patient had not recovered. Follow-up information was received from the registered nurse who reported that on 28-MAR-2011 at 11:30, the patient was vaccinated IM with the second dose of GARDASIL (lot # 667194/1271Z, expired date 11-DEC-2011) in her right arm. There was no illness at time of vaccination, pre-existing allergies, birth defects or medical conditions. Two days after immunization was given, on 30-MAR-2011 at 16:45, the patient developed generalized hives. She visited a doctor who described the symptoms as urticaria, unspecified. Patient started on ZYRTEC. At time of reporting, patient's status was recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human chorionic gonadotropin positive, Maternal exposure during pregnancy, Pharyngitis streptococcal, Rash, Urticaria
Clinical narrative: Information has been received from an approximately 20 year old female with no drug allergies and no medical histories, for GARDASIL, a Pregnancy Registry product, who "about one month ago", in approximately February 2011, was vaccinated with a first dose of GARDASIL (therapy route and lot # not provided). There was no concomitant medication. A few days after receiving her first dose of GARDASIL she developed a "weird rash", described as hives over her whole body (the hives moved from site to site). The rash has continued to the present even the patient used an "anti-itch" cream (cream unspecified). Two weeks ago, on approximately 17-MAR-2011, the patient also developed a "strep throat" which was treated with the antibiotic amoxicillin. The patient was late for her period and yesterday, on 30-MAR-2011s she did a urine pregnancy test and was told that she was pregnant. Her last menstrual period started from 01-FEB-2011 and ended on 05-FEB-2011. Her estimated delivery date was 08-NOV-2011. At the time of reporting, the patient's outcome of "strep throat" was unknown. Patient sought unspecified medical attentions. Follow up information has been received from the physician concerning the 20 year old female patient who on 02-MAR-2011 was vaccinated with the first dose of GARDASIL (lot number 663558/0819Y, exp date 10-OCT-2011). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with the first dose of GARDASIL (Lot# and expiration not reported). The physician reported that the patient received GARDASIL and had an episode of fainting. It was unspecified if the patient sought medical attention. At the time of reporting the patient was recovering. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from an office manager concerning a female who was vaccinated with GARDASIL (lot number: 662520/0120Y, dose, route not reported) for immunization. The patient finished HPV vaccination (name, manufacturer unspecified) but came down with positive result for HPV infection. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician (Local reference # CZE11/071) concerning a female patient who on an unspecified dates was vaccinated with a first and a second dose of GARDASIL (Route and Lot# not reported). The physician stated that on unspecified date the patient experienced fever (40 degrees C). The physician also stated that she did not administer the third dose. At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Information has been received from an approximately 17 year old female patient with Von Willebrand syndrome and allergy to latex who about 4 years ago on 01-JAN-2008 was vaccinated with the first dose of GARDASIL (Lot # and expire date not reported), 0.5 ml, intramuscularly. There was no concomitant medication. Patient stated that after she received the first dose of GARDASIL about 4 years ago, she was experiencing "dizziness, her legs going numb and shortness of breath". No treatment was given to the patient. There were no laboratory diagnostics studies performed. Therapy with GARDASIL was discontinued and no reintroduced. The patient did not seek medical attention. At the time of the report, the patient had recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot Number: 667866/1437Z). On an unspecified date the patient experienced pain in her arm after receiving the GARDASIL. It was unspecified whether the patient sought medical attention. At the time of the report, the patient's present status was unknown. A lot check has been initiated. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unknown date was vaccinated with a dose of GARDASIL injection (dose, route and lot number not provided). The nurse reported that on an unspecified date the patient experienced an injection site reaction after receiving GARDASIL injection. The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. This is one of three reports received from the same source. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Information has been received from an unspecified nurse concerning a "14 or 15 years old" (unsure of actual age) female patient who was vaccinated with her second dose of GARDASIL and a dose of MENACTRA date in the office. No dates were specified as to when any doses were received. Following the injections, the patient experienced diarrhea and stomach pain. It was not specified if anything was given for the symptoms or which medication caused the symptoms. The adverse events were recorded in regard to the GARDASIL. The patient did not seek any medical attention. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a mother concerning her daughter, a 23 year old female with no pertinent medical history and no drug reactions or allergies who on 25-MAY-2007 was vaccinated with the first dose of GARDASIL (route not provided). On 21-NOV-2007 the patient received her second dose of GARDASIL (route and lot number not provided) and the third dose of GARDASIL was received on 27-MAR-2008. (Lot number provided with unspecified information corresponds to each patient as below: 659437/1266U; 657736/0389U; 659182/1757U; 656051/0244U; 657617/0384U). Concomitant therapy included an unspecified drug for "birth control". The patient switched from YAZ to the unspecified birth control. The mother reported her daughter's two consecutive pap swears were abnormal. Third pap smears had been scheduled to check patient current status. If their follow up pap smear is abnormal the treatment being discussed/recommended is to freeze the cervix. Laboratory diagnostics studies included a yearly physical in August 2010, results not reported. The patient sought unspecified medical attention. Upon the time of report, the patient was not recovered. Follow up information has been received from a physician concerning a 23 year female who on 25-MAY-2007 was vaccinated in left arm with the first dose of GARDASIL (lot number: 657736/0389U). On 21-NOV-2007 the patient received the second dose of GARDASIL in left arm (Lot number: 659437/1266U) and on 27-MAR-2008 received the third dose of GARDASIL (Lot number: 659182/1757U) in left arm. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Condition aggravated, Headache, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a consumer for GARDASIL, a Pregnancy Registry product, concerning his 33 year old wife with no allergy or drug reactions history, sickle cell anemia and headaches who on 14-SEP-2010, was vaccinated with her first and only dose of GARDASIL (route and lot number not reported). It was reported by the husband that other vaccines were given on the same day, but "he did not known the names of them". Urine pregnancy test was performed on the patient was pregnant LMP: 08NOV-2011, EDD: 15-AUG-2011. The reporter stated that on an unspecified date, his wife was experiencing "belly pain and headaches" and she went to the local ER and an ultrasound was performed. The results showed that the "baby was good, everything was good". His wife was not hospitalized and she received as recommendation a follow up with the obstetrician. At the time of the report the outcome of the patient was unknown. No further information is available.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test urine positive, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a consumer for GARDASIL, a Pregnancy Registry product, concerning his 33 year old wife with no allergy or drug reactions history, sickle cell anemia and headaches who on 14-SEP-2010, was vaccinated with her first and only dose of GARDASIL (route and lot number not reported). It was reported by the husband that other vaccines were given on the same day, but "he did not known the names of them". Urine pregnancy test was performed on the patient was pregnant LMP: 08NOV-2011, EDD: 15-AUG-2011. The reporter stated that on an unspecified date, his wife was experiencing "belly pain and headaches" and she went to the local ER and an ultrasound was performed. The results showed that the "baby was good, everything was good". His wife was not hospitalized and she received as recommendation a follow up with the obstetrician. At the time of the report the outcome of the patient was unknown. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient whose the family had a history of cervical cancer who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # and expired date not reported), 0.5 ml. The physician stated that on an unspecified date, the patient experienced hives. The patient was given steroid as a treatment. The patient sought unspecified medical attention At the time of this report, patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a website concerning a female who on an unknown date, was vaccinated with a dose of GARDASIL (lot # not reported). On an unknown date, the patient experienced "horrific pain". It was reported that the patient 's brothers witnessed "the horrific pain and suffering" after the patient received GARDASIL . At the time of the report the outcome of the patient was unknown. This is one of two reports from the same source. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 21 year old female daughter allergic to codeine and a history of flu and bronchitis who on 25-MAR-2007, 21-NOV-2007, and 27-MAR-2008 was vaccinated with a dose of GARDASIL respectively (Lot number provided with unspecified information corresponds to each patient as below: 659437/1266U; 657736/0389U; 659182/1757U; 656051/0244U; 657617/0384U). Concomitant therapy included YAZ birth control previously and switched to new unspecified birth control. The mother had a list of the lot numbers and dates of administration, however she was unsure of which dates corresponded to this patient. The information she had came from a doctor's office where the patient received the vaccines. On an unspecified date, the patient experienced two abnormal pap smears and was scheduled for a third pap smear to determine current status. The patient sought medical attention. Laboratory diagnostics studies included a yearly physical in August 2010, results not reported. No treatment for the adverse event was given, however close monitoring was being executed. If the patient continued to receive abnormal pap smear results, it had been suggested that she had her cervix frozen through an in-office procedure. At the time of the report the patient was not recovered. This is one of two reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Laboratory test, Magnetic resonance cholangiopancreatography, Nuclear magnetic resonance imaging, Ultrasound scan
Clinical narrative: Information has been received from a consumer concerning the 21 year old daughter who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently the patient  had a reaction to the product. The patient had "many of the symptoms that a lot of the young ladies were blogging about via the internet". At the time of reporting, the patient had not recovered. It was unspecified if the patient sought medical attention. Follow-up information has been received from the consumer who reported that the patient had been to many hospitals and doctors. She had numerous tests and various types of x-rays, computed tomography (CT) scan, Magnetic resonance imaging (MRI), Magnetic resonance cholangiopancreatography (MRCP), sonogram etc (results not provided). No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication, X-ray
Clinical narrative: Information has been received from a consumer concerning the 21 year old daughter who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently the patient  had a reaction to the product. The patient had "many of the symptoms that a lot of the young ladies were blogging about via the internet". At the time of reporting, the patient had not recovered. It was unspecified if the patient sought medical attention. Follow-up information has been received from the consumer who reported that the patient had been to many hospitals and doctors. She had numerous tests and various types of x-rays, computed tomography (CT) scan, Magnetic resonance imaging (MRI), Magnetic resonance cholangiopancreatography (MRCP), sonogram etc (results not provided). No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant (also reported as "nurse practitioner") concerning an approximately 26 year old female with no pertinent medical history and no drug allergy or reaction who on 11-NOV-2010 was vaccinated IM with the second 0.5 ml dose of GARDASIL (Lot number: 662404/0312Y; expiration date: 03-APR-2011). There was no concomitant medication. At an unspecified time after the injection the patient reported that she developed redness, swelling and tenderness at the injection site that lasted for two months. Medical assistant reported that the patient reported that she did not experience a reaction to the first dose of GARDASIL. No lab diagnostics study was performed. The patient did not seek medical attention. At the time of the report, the patient's present status was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Nausea, Vertigo
Clinical narrative: Information has been received from a certified nurse concerning a 21 year old female patient with asthma, migraine and polycystic ovarian syndrome (PCOS) who on 17-SEP-2010 was vaccinated with the first dose of GARDASIL. (Lot number 667194/1081Z). Concomitant therapy included AVIANE. The nurse reported that the patient received the second dose of GARDASIL (Lot number 667194/1081Z, exp date 11-DEC-2012) on 14-JAN-2011 and immediately experienced, nausea, vertigo and for a short period of time. No labs diagnostics were performed. On 14-JAN-2011 the patient recovered from the experience. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 22 year old female with allergy to SEPTRA who on 07-FEB-2011 was vaccinated with the first dose of GARDASIL (lot # 666596/0414Z, exp. 15-OCT-2012). The reporter stated that the patient had a "swollen arm and throbbing arm pain which started approximately 2 weeks after the first dose of GARDASIL was given on 24-FEB-2011". No treatment was given for the adverse event. The reporter also stated that it took 11 days for the patient to recover (07-MAR-2011). It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a health care professional concerning an 18 year old female with HPV high risk, allergy to AMOX, BEANDRYL and penicillins who at 15:00 on 16-MAY-2011 was vaccinated with the third dose of GARDASIL (lot # 0299AA) in her right arm. On 17-MAY-2011, the patient noticed pink rash and tiny bumps where injection was given, and were sore. Patient did not get in reaction from the first shot. At the time of the report, the outcomes were unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthma, Malaise
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with asthma and no drug reactions or allergies, who on 03-OCT-2010 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included ADVAIR, montelukast sodium (MSD) and CLARINEX. The consumer mentioned on 14-NOV-2010, "6 weeks later" her daughter's asthma had acted up and her daughter was sick on and off. The consumer did not feel this was due to GARDASIL. No labs/diagnostics studies were performed. The patient was given cortisone and albuterol treatments for the events. It was reported that the patient recovered and was fine on 21-NOV-2010 "after 1 week" of treatment. The patient sought medical attention via an office visit. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Herpes virus infection
Clinical narrative: Information has been received from a male consumer who on 26-JAN-2011 and 26-MAR-2011 was vaccinated with his first and second doses of the GARDASIL vaccine in an unknown site (lot number not reported). The patient reported he experienced "getting herpes (not the human papillomavirus) after receiving all three doses of the GARDASIL shots." The company representative spoke to the GARDASIL helpline regarding the patient and was informed, "he purchased his first dose 26-JAN-2011 and received his second injection 26-MAR-2011. He sent in his rebate forms on 06-APR-2011, that should take six to eight weeks to process." The patient's outcome was unknown at the time of the report. The patient's event of getting herpes (not the human papillomavirus) after receiving all three doses of the GARDASIL vaccine in relation to therapy with the GARDASIL vaccine was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician and a medical assistant concerning a female patient who on approximately 21-MAR-2011 ("last week") was vaccinated with her second dose of GARDASIL (lot # not reported). On approximately 21-MAR-2011 immediately after receiving the vaccine, the patient fainted. The patient did not seek medical attention. Subsequently, the patient recovered from faint on an unspecified date on therapy (also reported as no treatment was given to the patient). The physician reported that the patient did not have any adverse effect from the dose of GARDASIL vaccinated on an unspecified date. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number and date of event. The medical assistant was asked to speak with the physician to see if the identities could be determine so that additional details might be obtained. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Nausea, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient with no allergies and no pertinent medical history who on 15-DEC-2010 was vaccinated with a first dose of GARDASIL (Lot # 666118/1539Y, exp date 10-AUG-2012), IM, and on 15-FEB-2011 was vaccinated with a second dose of GARDASIL (Lot # 666118/1539Y, exp date 10-AUG-2012), IM. There was not concomitant medication. The nurse stated that on 15-DEC-2010 the patient after the first dose of GARDASIL passed out in the lobby and within 10 minutes was feeling back to normal and on 15-FEB-2011 experienced lightheaded and clammy after the second dose of GARDASIL vaccine, but did not pass out. The nurse also stated that again within 10 minutes the patient was feeling back to normal. There were no laboratories diagnostics performed. There was no treatment given for the events. The patient sought unspecified medical attention. Follow-up information has been received which reported that the female student patient with no pre-existing allergies was vaccinated with a second dose of GARDASIL (lot # 666118/1539Y), IM on 15-FEB-2011 at 15:30. It was reported that on 15-DEC-2010 after received the first dose of GARDASIL the patient passed out and on 15-02-2011 after received the second dose of GARDASIL. The patient experienced clamminess, pallor and nausea but did not pass out remained seated for 15 minutes. It was also reported that the patient was completely recovered 20 minutes after each dose on same day of events. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Crying, Disorientation, Dizziness, Hyperventilation
Clinical narrative: Initial and follow up information has been received from a medical assistant and a physician concerning a 16 year old female patient who was vaccinated with GARDASIL dose 1 (lot # 659055/0560X) on 10-AUG-2009 and dose 2 (lot # 666931/0337Z) on 01-MAR-2011. No other vaccines administered on 01-MAR-2011, the date of event. The medical assistant reported that on 01-MAR-2011 the patient became disoriented and felt sick immediately after her second vaccination with GARDASIL. She was unable to recognize her father and could not see or hear anyone around her. She rested for about 20 minutes and was then fine. The physician described the patient as becoming dizzy and disoriented, she was weak and had a crying episode. At first, the physician thought the patient was hyperventilating so gave her a paper bag to breathe in; it was also suspected that the patient might be having a vasovagal episode; vital signs were normal (blood pressure was normal); there was no blindness or hearing loss, just a feeling that she was going to pass out - which the patient did not do. The patient was recovered from disoriented, felt sick and unable to recognize her father on 01-MAR-2011. The outcome of other events was unknown. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Malaise, Presyncope
Clinical narrative: Initial and follow up information has been received from a medical assistant and a physician concerning a 16 year old female patient who was vaccinated with GARDASIL dose 1 (lot # 659055/0560X) on 10-AUG-2009 and dose 2 (lot # 666931/0337Z) on 01-MAR-2011. No other vaccines administered on 01-MAR-2011, the date of event. The medical assistant reported that on 01-MAR-2011 the patient became disoriented and felt sick immediately after her second vaccination with GARDASIL. She was unable to recognize her father and could not see or hear anyone around her. She rested for about 20 minutes and was then fine. The physician described the patient as becoming dizzy and disoriented, she was weak and had a crying episode. At first, the physician thought the patient was hyperventilating so gave her a paper bag to breathe in; it was also suspected that the patient might be having a vasovagal episode; vital signs were normal (blood pressure was normal); there was no blindness or hearing loss, just a feeling that she was going to pass out - which the patient did not do. The patient was recovered from disoriented, felt sick and unable to recognize her father on 01-MAR-2011. The outcome of other events was unknown. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Headache, Migraine with aura, Muscle spasms
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no pertinent medical history and no drug reactions or allergies who on 29-MAR-2011 was vaccinated with the first dose of GARDASIL (route, dose and lot number not provided) at the patient's gynecologist office (name of gynecologist not reported). Concomitant therapy included oral contraceptives (unspecified). On 29-MAR-2011 at an unspecified time in the evening, the patient experienced abdominal pain, cramping and a low grade headache. The physician reported that the patient's abdominal pain and cramping subsided on 31-MAR-2011. The patient's low grade headache became worse and the patient came to the physician's office on 01-APR-2011 with an ocular migraine. The ocular migraine was alleviated with the use of MOTRIN (dose and manufacturer unspecified). The physician reported that the patient complained of "a little" dizziness on 01-APR-2011 "today". No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Condition aggravated, Human papilloma virus test positive, Maternal exposure before pregnancy, Papilloma viral infection
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with Papilloma viral infection and no known drug reactions or allergies, who on 28-JAN-2010, was vaccinated IM with the first 0.5ml dose of GARDASIL (lot number 663451/0216Y), on 30-MAR-2010 was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 663451/0216Y) and on 02-MAR-2011 was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot # not reported). Concomitant therapy included vitamins. It was her first pregnancy. The patient's LMP was on 21-APR-2010 and the estimated conception date was on 05-MAY-2010. It was reported that on 22-JUN-2010, the patient had an ultrasound performed at 11 weeks of gestation. On 09-JUL-2010, the patient had staphylococcus aureus infection. On 16-NOV-2010, the patient had an other ultrasound performed for fetus reason growth. The nurse reported that on 11-JAN-2011 the patient delivered a healthy male baby at 32 (also reported as 38 weeks by the physician) weeks LMP without any complications or medical reactions during pregnancy or labor. The baby's weight was 7 lb 4 oz. The patient did not have any complication during pregnancy labor. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Premature labour, Smear cervix abnormal, Staphylococcal infection, Staphylococcus test positive, Ultrasound antenatal screen
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with Papilloma viral infection and no known drug reactions or allergies, who on 28-JAN-2010, was vaccinated IM with the first 0.5ml dose of GARDASIL (lot number 663451/0216Y), on 30-MAR-2010 was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 663451/0216Y) and on 02-MAR-2011 was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot # not reported). Concomitant therapy included vitamins. It was her first pregnancy. The patient's LMP was on 21-APR-2010 and the estimated conception date was on 05-MAY-2010. It was reported that on 22-JUN-2010, the patient had an ultrasound performed at 11 weeks of gestation. On 09-JUL-2010, the patient had staphylococcus aureus infection. On 16-NOV-2010, the patient had an other ultrasound performed for fetus reason growth. The nurse reported that on 11-JAN-2011 the patient delivered a healthy male baby at 32 (also reported as 38 weeks by the physician) weeks LMP without any complications or medical reactions during pregnancy or labor. The baby's weight was 7 lb 4 oz. The patient did not have any complication during pregnancy labor. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Fatigue, Infectious mononucleosis, Rash, Yellow skin
Clinical narrative: Information has been received from a consumer concerning her 12 year old granddaughter who on unspecified date, was vaccinated with a dose of GARDASIL (lot number dose, site of administration not reported). Consumer reported that on unspecified date since the administration of the vaccine the patient experienced a rash, tiredness, yellowing of the kin and had missed school for two weeks. Antibiotics (manufacturer unknown) and steroids (manufacturer unknown) were given by her physician as treatment of adverse events. The physician diagnosed the patient  with "mono". The consumer reported that her granddaughter did not have "mono" and that these side effects were related to the administration of GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Information has been received from a physician concerning a female patient who in approximately March 2011, was vaccinated with the first single dose of GARDASIL, 0.5 ml, intramuscularly (lot number not reported). Within a "couple of days" of receiving GARDASIL, the patient experienced severe swelling of the lips in March 2011, two to three weeks ago. No lab diagnostics studies were performed. Swelling was treated with BENADRYL. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fall, Fatigue, Laboratory test, Laceration
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient with no pertinent medial history, no concurrent conditions and no known drug allergies, who on 27-JAN-2011 was vaccinated with the first dose of GARDASIL (lot #667866/1437Z). The medical assistant stated that there was no concomitant medication and no other vaccines were given on that day. The physician stated that the patient's parents reported that "after getting the GARDASIL", on an unspecified date, the patient had experienced malaise and feeling weak, lack of energy and tired. The physician also reported that on 28-FEB-2011, the patient was at home and experienced syncope, during which she fell and lacerated her chin on a table. Patient received sutures to treat the laceration. The physician stated that on 18-MAR-2011, the patient was referred to Infectious Disease and on 19-MAR-2011 went through the ER for lab work (results not available at the time of the report). The physician did not know if the patient was admitted At the time of the report, the adverse events did not improve and the patient present status was unknown. The physician stated that the adverse events were not disabling or life threatening, but could change with lab results. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Suture insertion, Syncope
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient with no pertinent medial history, no concurrent conditions and no known drug allergies, who on 27-JAN-2011 was vaccinated with the first dose of GARDASIL (lot #667866/1437Z). The medical assistant stated that there was no concomitant medication and no other vaccines were given on that day. The physician stated that the patient's parents reported that "after getting the GARDASIL", on an unspecified date, the patient had experienced malaise and feeling weak, lack of energy and tired. The physician also reported that on 28-FEB-2011, the patient was at home and experienced syncope, during which she fell and lacerated her chin on a table. Patient received sutures to treat the laceration. The physician stated that on 18-MAR-2011, the patient was referred to Infectious Disease and on 19-MAR-2011 went through the ER for lab work (results not available at the time of the report). The physician did not know if the patient was admitted At the time of the report, the adverse events did not improve and the patient present status was unknown. The physician stated that the adverse events were not disabling or life threatening, but could change with lab results. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Headache
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no drug allergy and no medical history who on 06-JUL-2009 was vaccinated with a first dose of GARDASIL (therapy route and lot # not provided). On 21-APR-2011 the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (lot # 667194/1081Z, expired date unspecified). There was no concomitant medication. 48 hours after the patient received her second dose of GARDASIL, on 23-APR-2011, the patient experienced severe abdominal pain. Patient stated that the abdominal pain was a 10 on a scale of 1 to 10 and 10 was the worst pain she could have experienced. It was also reported that the patient experienced a headache as well. "Today", on 25-APR-2011, patient was feeling better and was recovered. No lab diagnostics studies were performed. Patient had sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Haemoglobin normal, Injection site reaction, Mean cell haemoglobin decreased, Mean platelet volume increased
Clinical narrative: Information has been received from a health care worker concerning a 12 year old female patient with no pertinent medical history and no drug reactions who on 21-JUL-2010 was intramuscularly vaccinated with the first dose of 0.5ml GARDASIL (lot# not reported), the second dose (lot# not reported) on 29-OCT-2010 and the third dose (lot# 666597/0768Z) on 15-MAR-2011. There was no concomitant medication. On 18-MAR-2011, the patient developed purpura type rash on both arms. It started as a small bruising and the area got bigger and turned to rash. Then the rash spread to the other arm. The patient did not have any problems with the first and second dose of GARDASIL. Base line complete blood cell count (CBC) was performed with no results reported. The patient sought unspecified medical attention. There was no treatment given for the event. At the time of reporting, the patient had not recovered and would be seeing an infectious disease specialist. Additional information was received from a physician and medical records regarding a 12 year old female. On 15-MAR-11, the patient received a GARDASIL (lot# 666597/0768Z) injection intramuscularly in her left deltoid. The patient had received two previous doses on 21-JUL-10 and 29-OCT-10. No other illnesses were documented at the time of vaccination. On 18-MAR-11, the patient started to experience left deltoid bruising. On 19-MAR-11, the patient experienced a petechial type rash on her left upper arm/ deltoid region. A complete blood count (CBC) test revealed white blood cell count (WBC) 4.5 and mean platelet volume (MPV) was 10.5 fl. All other values were within normal range. On 21-MAR-11, the patient experienced purpura/ ecchymosis on her left arm to wrist and she developed a rash on her right deltoid. On 23-MAR-11, the patient was taken to the emergency department where additional labs were drawn (results were not provided). On 24-MAR-11, the rash on the patient's right arm had spread to her wrist and continued on the other side. On 31-MAR-11, urinalysis revealed trace leukocyte esterase. The patient's rash had almost resolved. The patient had an appointment with an infectious disease specialist on 25-APR-11 for follow-up. Additional information has been requested. All available medical records will be provided upon request.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle injury, Petechiae, Purpura, Rash, Urine leukocyte esterase positive
Clinical narrative: Information has been received from a health care worker concerning a 12 year old female patient with no pertinent medical history and no drug reactions who on 21-JUL-2010 was intramuscularly vaccinated with the first dose of 0.5ml GARDASIL (lot# not reported), the second dose (lot# not reported) on 29-OCT-2010 and the third dose (lot# 666597/0768Z) on 15-MAR-2011. There was no concomitant medication. On 18-MAR-2011, the patient developed purpura type rash on both arms. It started as a small bruising and the area got bigger and turned to rash. Then the rash spread to the other arm. The patient did not have any problems with the first and second dose of GARDASIL. Base line complete blood cell count (CBC) was performed with no results reported. The patient sought unspecified medical attention. There was no treatment given for the event. At the time of reporting, the patient had not recovered and would be seeing an infectious disease specialist. Additional information was received from a physician and medical records regarding a 12 year old female. On 15-MAR-11, the patient received a GARDASIL (lot# 666597/0768Z) injection intramuscularly in her left deltoid. The patient had received two previous doses on 21-JUL-10 and 29-OCT-10. No other illnesses were documented at the time of vaccination. On 18-MAR-11, the patient started to experience left deltoid bruising. On 19-MAR-11, the patient experienced a petechial type rash on her left upper arm/ deltoid region. A complete blood count (CBC) test revealed white blood cell count (WBC) 4.5 and mean platelet volume (MPV) was 10.5 fl. All other values were within normal range. On 21-MAR-11, the patient experienced purpura/ ecchymosis on her left arm to wrist and she developed a rash on her right deltoid. On 23-MAR-11, the patient was taken to the emergency department where additional labs were drawn (results were not provided). On 24-MAR-11, the rash on the patient's right arm had spread to her wrist and continued on the other side. On 31-MAR-11, urinalysis revealed trace leukocyte esterase. The patient's rash had almost resolved. The patient had an appointment with an infectious disease specialist on 25-APR-11 for follow-up. Additional information has been requested. All available medical records will be provided upon request.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: White blood cell count decreased
Clinical narrative: Information has been received from a health care worker concerning a 12 year old female patient with no pertinent medical history and no drug reactions who on 21-JUL-2010 was intramuscularly vaccinated with the first dose of 0.5ml GARDASIL (lot# not reported), the second dose (lot# not reported) on 29-OCT-2010 and the third dose (lot# 666597/0768Z) on 15-MAR-2011. There was no concomitant medication. On 18-MAR-2011, the patient developed purpura type rash on both arms. It started as a small bruising and the area got bigger and turned to rash. Then the rash spread to the other arm. The patient did not have any problems with the first and second dose of GARDASIL. Base line complete blood cell count (CBC) was performed with no results reported. The patient sought unspecified medical attention. There was no treatment given for the event. At the time of reporting, the patient had not recovered and would be seeing an infectious disease specialist. Additional information was received from a physician and medical records regarding a 12 year old female. On 15-MAR-11, the patient received a GARDASIL (lot# 666597/0768Z) injection intramuscularly in her left deltoid. The patient had received two previous doses on 21-JUL-10 and 29-OCT-10. No other illnesses were documented at the time of vaccination. On 18-MAR-11, the patient started to experience left deltoid bruising. On 19-MAR-11, the patient experienced a petechial type rash on her left upper arm/ deltoid region. A complete blood count (CBC) test revealed white blood cell count (WBC) 4.5 and mean platelet volume (MPV) was 10.5 fl. All other values were within normal range. On 21-MAR-11, the patient experienced purpura/ ecchymosis on her left arm to wrist and she developed a rash on her right deltoid. On 23-MAR-11, the patient was taken to the emergency department where additional labs were drawn (results were not provided). On 24-MAR-11, the rash on the patient's right arm had spread to her wrist and continued on the other side. On 31-MAR-11, urinalysis revealed trace leukocyte esterase. The patient's rash had almost resolved. The patient had an appointment with an infectious disease specialist on 25-APR-11 for follow-up. Additional information has been requested. All available medical records will be provided upon request.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who in approximately 2010, "about a year ago", was vaccinated IM with the first 0.5ml dose of GARDASIL. In approximately 2010, "about a year ago", the patient experienced nauseousness and dizziness after receiving her first injection of GARDASIL. The patient was still experiencing these symptoms a year later. It was unknown if the patient sought medical attention. Therapy with GARDASIL was discontinued after first dose a year ago and not reintroduced. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Infectious mononucleosis
Clinical narrative: Information has been received from a certified medical assistant concerning a 24 year old female with no pertinent medical history and no drug reactions or allergies who on 09-MAR-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot Number: 667866/1437Z; Expiration date: 25-FEB-2013). There was no concomitant medication. Recently, on an unspecified date, the patient was diagnosed with infectious mononucleosis. The patient was seen by family physician and sought medical attention. Upon the time of the report, the patient was not recovered. Follow up information has been received from the medical assistant reported that the 24 year old female student with no illness at time of vaccination was diagnosed of infectious mononucleosis which was active when due for the second dose. The second dose was held until the patient recovered. At the time of the report, the patient's present status was unknown. Additional information has been requested.