chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not provided), and subsequently developed lymph node swelling under her arms.  She recovered from the event (duration not specified).  On an unspecified date, she was vaccinated with the second dose of Gardasil (lot # not provided), and again developed the lymph node swelling under her arms.  The patient recovered after an unspecified duration of time.  Additional information has been requested. 04/07/2008 Initial and follow up information has been received from a physician, concerning a 14 year old (previously reported as 12 year old) female student with no pertinent medical history, who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not provided), and subsequently developed lymph node swelling under her arms. There was no illness at the time of vaccinations. She recovered from the event (duration not specified). On 05-DEC-2007, she was vaccinated IM with the second dose of GARDASIL (lot # 659055/1522U), and again developed lymphadenopathy of the axilla. The student recovered after an unspecified duration of time. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not specified), who on 07-OCT-2007 was vaccinated with the first dose of Gardasil (lot # not reported). On 11-OCT-2007 the patient developed lymph node swelling in her neck. On 11-DEC-2007, the patient presented to the physician's office to receive her second dose of Gardasil, and informed the physician of her symptoms. The physician confirmed that bilateral lymph node swelling was still present at the visit. It was unknown if the patient received the second dose of Gardasil. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician, concerning a 10 year old female patient with no pertinent medical history and no known allergies, who on 11-OCT-2007 was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not reported).  There was no concomitant medication.  On 11-OCT-2007, following the vaccination (time to onset not specified), the patient experienced dizziness.  She was seen by the physician (details not provided).  After an unknown duration of time, she recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site anaesthesia, Injection site reaction, No reaction on previous exposure to drug, Paraesthesia, Tremor
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) who on 29-NOV-2007 was vaccinated (route and site not reported) with the 2nd dose of Gardasil (lot# not reported).  On 29-NOV-2007, post vaccination, the patient experienced tingling and numbness at injection site, in her fingertips and toes and she felt shaky.  The patient did not have this experience with the 1st dose (date unknown).  The patient did receive unspecified medical attention.  At the time of this report the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Hypoaesthesia, Muscular weakness
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated IM with a dose of Gardasil.  Subsequently the patient experienced weakness and numbness in the arm the injection was given.  The patient was also not as talkative as she normally is.  It was unknown whether medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Influenza like illness, Injection site pain, Malaise, Myalgia
Clinical narrative: Information has been received from a health professional concerning a 33 year old female who on 07-DEC-2007 was vaccinated IM in the left deltoid with the first dose of Gardasil (659055/1522U).  On 07-DEC-2007 the patient experienced injection site pain. The patient's injection site pain started shortly after vaccination with Gardasil and resolved the next day.  On 08-DEC-2007 the patient experienced body rash, muscle aches and malaise.  The rash on the patient's chest was the size of her palm, red and itchy.  After the rash the patient developed muscle aches over the whole body and flu-like symptoms.  The patient stated that "she felt like she was run over by a truck".  The muscle aches and flu symptoms resolved by 10-DEC-2007.  The patient still has the rash as of 11-DEC-2007.  The patient sought unspecified medical attention.  There is no other information to report.  Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a health professional concerning a 33 year old female who on 07-DEC-2007 was vaccinated IM in the left deltoid with the first dose of Gardasil (659055/1522U).  On 07-DEC-2007 the patient experienced injection site pain. The patient's injection site pain started shortly after vaccination with Gardasil and resolved the next day.  On 08-DEC-2007 the patient experienced body rash, muscle aches and malaise.  The rash on the patient's chest was the size of her palm, red and itchy.  After the rash the patient developed muscle aches over the whole body and flu-like symptoms.  The patient stated that "she felt like she was run over by a truck".  The muscle aches and flu symptoms resolved by 10-DEC-2007.  The patient still has the rash as of 11-DEC-2007.  The patient sought unspecified medical attention.  There is no other information to report.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning his twin teenage daughters who were vaccinated IM with a first 0.5 ml dose of Gardasil.  Subsequently the patients fainted after receiving the vaccination.  Both girls also received their second dose with no reaction.  Medical attention was not sought.  The patients were recovered.  No product quality compliant was involved.  This is one of the multiple reports from the same source.  Additional information has been requested. 02/10/2010 Information has been received from a physician concerning his 17 year old daughter with no allergies who on 05-OCT-2007 at 11:45 was vaccinated with IM witha a first 0.5ml dose of GARDASIL. The patietn fainted after receiving the vaccination. Medical attention was not sought. On 06-OCT-2007 the patient recovered. It was reporte that after the second dose the patient had not reaction. No product quality complaint was involved. It was also requested that the patient and her sibling faint if they receive any injection or lab work. They also faint if they are in the office for an extended period of time. It has been going on their entire life since age 5. If one sister was ill and received treatment or lab work the other sister who was not ill will faint. Their father isa also a fainter. The patient's twin sister also fainted after receiving a dose of GARDASIL (WAES#0712USA08229). Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Dizziness, Fatigue, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a female "between 13 and 15" who in approximately October 2007, was vaccinated with the second dose of Gardasil.  Subsequently, the patient experienced "2 weeks to a month of severe muscle pain and very sleepy mono-like symptoms".  The patient recovered from her severe muscle pain and very sleepy mono-like symptoms.  The patient sought unspecified medical attention.  Lab diagnostic studies included a "mono test and liver test that both results came out fine."  Per the reporter, the patient did not have any adverse reaction with the first dose of Gardasil.  The lot numbers were unavailable and no further information was provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008. Information has been received from a physician concerning a 14 year old female who on 14-JUN-2007, was vaccinated intramuscularly with the first dose of GARDASIL (657736/0389U). On 06-SEP-2007 the patient was vaccinated with the second dose of GARDASIL. Also, the patient complained of right hip pain at the time of the second vaccination. On 11-SEP-2007 the patient reported leg and right hip pain. One week later, on 18-SEP-2007 the patient reported having back and hip pain as well as general muscle aches. The patient was also very tired and falling asleep at school and experiencing dizziness. By 25-SEP-2007 the patient was feeling better. Per the reporter, the patient had recovered by 16-OCT-2007. Lab diagnostic studies included a complete metabolic panel, CBC, mon test, liver A1C test, and 2 series of x-rays of the right hip and pelvis. All labs were unremarkable. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Liver function test normal, Myalgia, Pain in extremity, Somnolence
Clinical narrative: Information has been received from a physician concerning a female "between 13 and 15" who in approximately October 2007, was vaccinated with the second dose of Gardasil.  Subsequently, the patient experienced "2 weeks to a month of severe muscle pain and very sleepy mono-like symptoms".  The patient recovered from her severe muscle pain and very sleepy mono-like symptoms.  The patient sought unspecified medical attention.  Lab diagnostic studies included a "mono test and liver test that both results came out fine."  Per the reporter, the patient did not have any adverse reaction with the first dose of Gardasil.  The lot numbers were unavailable and no further information was provided.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008. Information has been received from a physician concerning a 14 year old female who on 14-JUN-2007, was vaccinated intramuscularly with the first dose of GARDASIL (657736/0389U). On 06-SEP-2007 the patient was vaccinated with the second dose of GARDASIL. Also, the patient complained of right hip pain at the time of the second vaccination. On 11-SEP-2007 the patient reported leg and right hip pain. One week later, on 18-SEP-2007 the patient reported having back and hip pain as well as general muscle aches. The patient was also very tired and falling asleep at school and experiencing dizziness. By 25-SEP-2007 the patient was feeling better. Per the reporter, the patient had recovered by 16-OCT-2007. Lab diagnostic studies included a complete metabolic panel, CBC, mon test, liver A1C test, and 2 series of x-rays of the right hip and pelvis. All labs were unremarkable. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with no pertinent medical history who on an unspecified date was vaccinated with a second dose of Gardasil (lot # unknown).  Concomitant therapy included (dip toxoid) (MENACTRA).  On an unspecified date, "almost immediately after receiving the vaccine", the patient had "fainted and felt dizzy".  No further information was provided.  Medical attention was not sought.  At the time of reporting it was unknown if the patient had recovered.  Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional with high cholesterol and no known drug allergies/reactions who on unspecified dates was vaccinated with the first two doses of Gardasil (lot # unknown) IM.  Concomitant therapy included rosuvastatin calcium (CRESTOR), (therapy unspecified) (LOVAZA), omeprazole, niacin (NIASPAN) and aspirin.  Subsequently on unknown dates the health professional experienced pain at the injection site with the first two doses.  Medical attention was sought.  At the time of reporting the health professional had recovered.  No additional information at this time.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test positive, Ear, nose and throat examination normal, Nuclear magnetic resonance imaging normal, Tinnitus
Clinical narrative: Information has been received from a health professional concerning a 25 year old female with a history of food allergies who on 06-JUN-2007 was vaccinated intramuscularly in the left deltoid with her first dose of Gardasil (lot# 0469U). On 07-AUG-2007 the patient was vaccinated intramuscularly in the left deltoid with her second dose of Gardasil. On 08-AUG-2007 the patient experienced ringing in the left ear which still persists. The patient had extensive testing and follow up with specialists to find out the cause of the ringing in her left ear. The patient had a normal Brain MRI and a normal ENT check up. The patient was treated with a water pill, VALTREX and MEDROL Pak. The patient sought medical attention in the office. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: DTAP, HPV4, IPV, MEN
Symptoms: Syncope, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 15 year old white female who on 03-DEC-2007 was vaccinated with Gardasil (lot#659055/1522U).  Concomitant therapy included DTAP-IPV and meningococcal vaccine (unspecified).  Subsequently the patient fainted after the vaccination.  Unknown medical attention was sought.  The patient's outcome is unknown.  No product quality complaint was involved.  This is one of multiple reports from the same source.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Information has been received from a health professional concerning a 23 year old white female (70 in., 199 lb.) with no pre-existing allergies, birth defects or medical conditions who on 14-NOV-2007 (at 15:30) was vaccinated with her initial dosage of Gardasil (lot # 659437/1266U), IM, in the left deltoid.  On 14-NOV-2007 (at 15:30) the patient felt lightheaded, got dizzy and passed out.  It was reported the patient recovered from the event on the same day.  It was reported the patient had no illness at the time of vaccination.  Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse, concerning her 24 year old daughter with no known allergies and a history of an papilloma viral infection (HPV) and a loop electrosurgical excision procedure (LEEP) (July 2006), who on 21-MAY-2007 was vaccinated with the first dose and on 31-JUL-2007 with the second dose of Gardasil (lot # not reported).  There was no concomitant medication.  Following the second vaccination (date and duration not specified), her daughter had an abnormal papanicolaou (PAP) smear (details not provided), and sought unspecified medical attention.  At the time of this report, her daughter had not recovered.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner, concerning a 16 year old female patient with no known allergies and a history of an abnormal Papanicolaou (Pap) smear and a cervical biopsy, who on 17-SEP-2007 was vaccinated IM, with a dose, 0.5 ml, of Gardasil (lot #658558/1061U).  There was no concomitant medication.  On 19-SEP-2007, 48 hours after vaccination, the patient developed hives.  The patient's mother contacted the physician, but no treatment was required and the hives subsequently resolved (duration not specified).  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a nurse practitioner concerning a female with no known allergies and no reported medical history who on 10-DEC-2007 was vaccinated with Gardasil intramuscularly.  Concomitant therapy included MENACTRA in the same arm as the Gardasil vaccination.  On 11-DEC-2007 the patient experienced numbness in her fingers and fingertips, and had described that it almost felt like she had slept on her arm.  It was also reported that the patient was holding her arm as if it were in a sling because it was so sensitive.  No further information was provided and no lot number was given.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who was vaccinated with Gardasil and passed out.  Subsequently the patient recovered.  No further information was provided.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pharyngolaryngeal pain, Respiratory tract congestion
Clinical narrative: Information has been received through the Merck pregnancy registry through a physician concerning a 17 year old female with a history of an abnormal Papanicolaou smear followed by a normal Papanicolaou smear who on 31-JUL-2007 was vaccinated with her first dose of Gardasil (Lot # 657622/0388U).  On 08-NOV-2007, the patient was vaccinated with her second dose of Gardasil (Lot # 657868/0523U).  Concomitant therapy included albuterol inhaler, as needed.  Subsequently, the patient found out she was pregnant (LMP approximately 31-OCT-2007).  The patient is currently experiencing congestion and a sore throat.  The patient sought unspecified medical attention with an office visit.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Ultrasound Doppler
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who was recently (exact date not reported) vaccinated (route and site not reported) with Gardasil (lot # not reported).  Seven to eight days post vaccination the patient's "entire arm swelled up".  The physician performed a test on the patient to determine it was not cellulitis or a blood clot.  A Doppler test was performed, results were not reported.  At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a consumer concerning a daughter of a friend who on an unspecified date was vaccinated with Gardasil (Lot# not provided).  The consumer reported that her "friends daughter had the Gardasil vaccine and had a near death experience".  It was not reported if the patient sought medical attention for the event.  No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a physician concerning a few patients (ages and genders unknown), who, on an unspecified date, were vaccinated with a dose of Gardasil.  Subsequently, the patients had reactions after receiving the vaccination.  The specified reaction was not provided by the physician.  At the time of the report, the outcomes of the patients were unknown.  No product quality complaint was involved.  This is one of three reports from the same source.  Additional information is not available.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently, the patient fainted.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  This is one of three reports from the same source.  Additional information is not available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who on 30-NOV-2007 was vaccinated IM with a 0.5 ml second dose of Gardasil (lot# 659439/1267U). On 16-DEC-2007 the patient developed golf ball sized lump at the injection site. Medical attention was sought.  The patient was treated with unspecified antibiotics.  At the time of reporting the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.  This is in follow-up to report(s) previously submitted on 1/15/2008. Information has been received from a licensed practical nurse concerning a 21 year old female patient with no medical history or allergies who on 30-NOV-2007 was vaccinated IM with a 0.5 ml second dose of GARDASIL (lot# 659439/1267U). There was no concomitant medications. On 17-DEC-2007, the patient went to the physician's office to have her arm checked. It was reported that her left arm was swollen and painful where she got the vaccine. The day before yesterday the patient started having tenderness in her upper left deltoid. It was noted that it had been nearly two weeks since she received the vaccine. The are was minimally swollen, slightly tender to pressure, no redness, no identifiable, visual abnormality. Assuming that it might have been due to the vaccine and possibly bacterial in origin, the physician gave the patient CIPRO 250 mg three times a day for 5 days, but asked her to return in 48 hours to re-evaluate. On 19-DEC-2007, the patient went back to the physician's office for a re-evaluation. The patient's left upper arm was still slightly tender, but she felt it was less so. Her arm also felt less full. There was no redness, minimal swelling and minimal tenderness on direct palpation. The patient was given instructions to call in a couple of weeks if the pain was still present and to call any time sooner if there was an increase in pain, redness, fever, etc. At the time of reporting the patient was recovering. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inflammation, No reaction on previous exposure to drug, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 22 year old female with a history of positive for antibodies for herpes virus of unknown type, who on 12-JUN-2007 was vaccinated with the first dose of Gardasil and the PAP test done on that day was normal.  On 16-Aug-2007 the patient received the second dose and on 04-Dec-2007 received the third dose and a PAP test taken that day was positive for high risk HPV.  Medical attention was sought.  At the time of report the patient had not recovered.  No product quality compliant was involved.  Additional information has been requested. 02/10/2010 On 12-Jun-2007 the patient received the second dose IM in the right deltoid and tjet pap test done that day was normal with candids inflammed, and on 04-Dec-2007 received the third dose IM in the left deltoid and an PAP test tanke that day was positive for high risk HPV. Concomitant medication included Othro trycyclan to SC pills (manufacturer unknown). Medical attention was sought. At the time of report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with an initial 0.5 ml first dose of Gardasil.  Subsequently, one day after vaccination, the patient developed a fever.  At the time of the report the patient's outcome was unknown.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a physician concerning a female who on 17-NOV-2007 was vaccinated with her first dose of Gardasil.  On 18-NOV-2007 the patient experienced severe stomach cramps.  Subsequently, the patient recovered from severe stomach cramps and sought unspecified medical attention.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history who in August 2007, was vaccinated with a first dose of Gardasil.  There was no concomitant medication.  In August 2007, in the office, the patient became "queasy, pale, lightheaded and dizzy".   There was no laboratory or diagnostic tests performed.  In August 200, "after about a half hour" the patient recovered.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Condition aggravated, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 30-APR-2007 was vaccinated with a first dose of Gardasil.  She received her second dose of Gardasil on 12-DEC-2007.   The physician reported that the patient developed a "flare up" of genital warts after receiving the second injection.  The patient reported that the non specific increase in amount of genital warts began about one month after the patient received the first dose of Gardasil on 30-APR-2007.  The physician stated he did not examine the patient and the symptoms were self reported.  Additionally, the patient reported the increase in genital warts to the patient's gynecologist (unspecified name).  No other symptoms and no other information available at the time of this report.  The outcome was unknown.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chlamydial infection, Drug exposure during pregnancy, Ultrasound uterus, Upper respiratory tract infection
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 21 year old female with a history of radiation exposure, alcohol use and IV drug use who on 27-SEP-2007 was vaccinated with her first dose of Gardasil (Lot #1063U/Batch #658563) intramuscularly in the left deltoid. Concomitant therapy included OMEGA-3). On 10 19-OCT-2007 the patient tested positive for Chlamydia. On 05-DEC-2007 the patient had a upper respiratory infection and was treated with ZITHROMAX Z-Pack). The patient was also taking prenatal vitamins (unspecified). Her estimated date of confinement is 25-JUN-2008 and LMP was 26-SEP-2007. The patient also had an ultrasound on 21-NOV-2007 which showed intrauterine pregnancy x 1 with a heart rate of 169 beats/minute. There are no other details. The nurse reported that a patient who received one dose of Gardasil was pregnant. No symptoms reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pharyngeal oedema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 17 year old female with anxiety and no reported allergies who on 10-DEC-2007 was vaccinated with 0.5 ml Gardasil intramuscularly.  Concomitant therapy included hormonal contraceptives (unspecified).  On 11-DEC-2007 the patient developed swelling of the throat.  Patient said that it felt like her throat was swelling shut.  The patient's mother was instructed to administer BENADRYL to her.  The patient recovered and went to work on 11-DEC-2007.  Additional information has been requested. 04/07/2008 Information has been received from a licensed practical nurse concerning a 17 year old female with anxiety and no reported allergies who on 10-DEC-2007 was vaccinated with 0.5 ml GARDASIL intramuscularly. Concomitant therapy included hormonal contraceptives (unspecified). On 11-DEC-2007 the patient developed swelling of the throat and slight nausea. Patient said that it felt like her throat was swelling shut. The patient's mother was instructed to administer BENADRYL to her. It was noted that the patient also took CELEXA for the first time on 11-DEC-2007. The patient recovered and went to work on 11-DEC-2007. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from the mother of a consumer concerning her 16 year old daughter with acne who on an unspecified date in June 2007, was vaccinated with the first dose of Gardasil (Lot# not reported).  Concomitant therapy included antimicrobial (unspecified).  On an unspecified date in October 2007, the patient was vaccinated with the second dose of Gardasil (Lot# not reported).  Subsequently within 24 hours post vaccination her daughter developed a rash, which began as a few bumps on her torso in the mid-back and on her stomach area under the breast bone".  The consumer reported that over the past several weeks the rash became more pronounced and her daughter was seen by a dermatologist.  The date of this appointment and any treatment information was not provided.  The mother reported that her daughter had no reactions after her first dose of the vaccine.  At the time of this report the patient had not recovered from the rash. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first two doses of Gardasil.  Subsequently the patient experienced abdominal pain and dizziness after each dose.  The side effects were ceased but no time frame was provided.  The patient will not be receiving the third dose.  Unknown medical attention was sought.  The patient recovered.  No product quality compliant was involved.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site rash, Injection site vesicles, Mobility decreased, Muscular weakness
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female, who, on an unspecified date, was vaccinated with a second dose of Gardasil.  Subsequently, the patient developed an injection site rash and injection site soreness.  The patient contacted the physician.  At the time of the report, the outcome of the patient was unknown.  No product quality compliant was involved.  Additional information has been requested. 07/08/08 Initial and follow-up information has been received from a registered nurse concerning a 27 year old female with an allergy to codeine, who on 07-DEC-2007 at 09:30 was vaccinated in the left deltoid with a second dose of GARDASIL (Lot# 659055/1522U). There were no illnesses at the time of the vaccination. On 07-DEC-2007 at approximately 10:30 the patient experienced a weak arm, the patient developed an injection site rash, and injection site soreness. The weak arm lasted for 4 weeks after the injection. The patient could not lift a hose. Around the third day post vaccination the patient developed "blister like fever blisters" all around the injection site. The blisters lasted seven to ten days. The patient was seen by the physician and was instructed to take BENADRYL. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a 25 year old male who was vaccinated with a dose of Gardasil because he was tested positive for HPV.  It was unknown whether medical attention was sought.  Patient's outcome was unknown.  No product quality compliant was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a female who in October 2007, was vaccinated with Gardasil.  After the vaccination the patient developed a local reaction at the injection site.  The area was red, swollen, and hot.  Medical attention was sought.  The patient did not respond to antihistamines but symptoms did respond after an antibiotic was started.  At an unknown date the patient was recovered.  No product quality compliant was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood urea nitrogen/creatinine ratio increased, Eosinophil count abnormal, Lymphadenopathy, Mean cell haemoglobin increased, Streptococcal identification test
Clinical narrative: Information has been received from a nurse concerning a 16 year old white female who on 09-JAN-2007, 6-Apr-2007 and 23-Jul-2007 was vaccinated intramuscularly in the left arm with the 1st (lot #654702/0011U), 2nd (lot #657006/0188U) and 3rd (658100/0525U) dose of Gardasil respectively.  On 29-Nov-2007 the patient reported left submandibular superior anterior cervical node swelling for the last 2-3 months.  Nodes enlarge and subside within hours.  The symptoms started in September 2007 (exact date not reported).  The patient received unspecified medical attention.  A rapid strep test was performed, results were negative.  A chemistry panel was run, results were within normal limits with exception to MCHC - high, Eosinophils, Absolute - low, Bun/Creatinine ratio - high.  The patient's outcome was not reported.  No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Streptococcal identification test negative
Clinical narrative: Information has been received from a nurse concerning a 16 year old white female who on 09-JAN-2007, 6-Apr-2007 and 23-Jul-2007 was vaccinated intramuscularly in the left arm with the 1st (lot #654702/0011U), 2nd (lot #657006/0188U) and 3rd (658100/0525U) dose of Gardasil respectively.  On 29-Nov-2007 the patient reported left submandibular superior anterior cervical node swelling for the last 2-3 months.  Nodes enlarge and subside within hours.  The symptoms started in September 2007 (exact date not reported).  The patient received unspecified medical attention.  A rapid strep test was performed, results were negative.  A chemistry panel was run, results were within normal limits with exception to MCHC - high, Eosinophils, Absolute - low, Bun/Creatinine ratio - high.  The patient's outcome was not reported.  No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Disturbance in attention
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil.  The physician reported that after the first injection the patient experienced confusion and lack of concentration.  No further information provided.  The outcome was unknown.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter who had no relevant medical history or drug reactions/allergies, who in September 2007 (exact date not reported), was vaccinated (site and route not reported) with the 3rd dose of the Gardasil vaccine (lot # not reported).  The patient was concomitantly taking fish oil.  The patient's mother reported that her daughter had an abnormal pap smear.  The patient's mother was told that the, "the pap smear showed abnormal cell growth".  The patient was scheduled for cryosurgery for 18-Dec-2007.  At the time of this report the patient had not recovered.  Additional information has been requested. Information has been received from a registered nurse concerning her 22 year old daughter who has no relevant medical history or drug reactions/allergies, who on unspecified date was vaccinated with a first and second dose of HPV vaccine (lot #, route and site not reported) in September 2007 (exact date not reported), was vaccinated (site and route not reported) with the 3trd dose of the HPV vaccine (lot # not reported). The patient was concomitnantly taking fish oil. The patient's mother reported that her daughte had an abnormal pap smear. The patient's mother was told  that the "the pap smear showed abnormal cell growth". The patient was scheduled for cryosurgery for 18-Dec-2007. At the time of this report the patient had not recovered. Follow up information was received on 24-MAR-2008. The registered nurse reported that her daughter's biopsy was negative and the her daughter recovered (date unspecified) from her outpatient procedure. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with asthma who on 18-Dec-2007 was vaccinated with her first dose of Gardasil (Lot #659652/1448U).  Concomitant therapy included hormonal contraceptives (unspecified).  About 15 minutes post vaccination the patient developed a cold sweat and nausea.  She was observed for about 20 minutes and was allowed to leave when the symptoms subsided.  No other information was available.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with no relevant medical history, drug reactions/allergies or concomitant medication usage who on 10-OCT-2007 was vaccinated intramuscularly (site not reported) the 1st 0.5ml dose of Gardasil (lot # not reported).  On approximately October 12-13, 2007, two or three days post vaccination, the patient developed widespread, migrating myalgia.  The patient was examined in the office.  The patient fully recovered from myalgia within 3 weeks without requiring treatment.  The patient was scheduled to receive the 2nd dose of Gardasil vaccine on 18-Dec-2007.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female with a history endometriosis (laparoscopic surgery 29-Oct-2007) and no known drug reactions/allergies who on 03-DEC-2007 was vaccinated intramuscularly in the right deltoid muscle with the 1st 0.5ml dose of GARDASIL vaccine (lot#659439/1267U). Concomitant therapy included leuprolide acetate injection (LUPRON DEPOT) received on 03-Dec-2007. Subsequently, post vaccination (date was not reported), the patient experienced nausea, vomiting, a fever and developed a unspecified rash from the waist down. The patient was seen by the physician on 18-Dec-2007 and received unspecified medical attention. No diagnostic lab test were performed. At the time of this report it was unknown if the patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Menstruation irregular
Clinical narrative: Information has been received from a nurse concerning her 15 year old daughter with no pertinent medical history, drug reactions/allergies or concomitant medication usage, who in December 2008 (exact date not reported), was vaccinated (site and route not reported) with the 1st dose of GARDASIL (lot# not reported). In January 2007 (exact date not reported), the patient experienced irregular menstrual period. In June 2007 (exact date not reported), the patient was vaccinated (site and route not reported) with the 2nd dose of GARDASIL (lot# not reported), the patient has not received her third dose of GARDASIL. The patient did receive unspecified medical attention and at the time of this report had not recovered. Additional information has been requested. 2/12/2010 follow up- menstruation irregular: inappropriate schedule of drug administration  information has been received from a nurse concerning her 15 year old daughter with no pertinent medical history, drug reactions/allergies or concomitant medication usage, who in december 2006(exact date not reported) was vaccination site and route was not reported. with the 1st dose of HPV 6 11 16 VLF vaccine [yeast] [lot# not reported]- in january 2007 (exact date not reported). the patient experienced irregular menstrual period. in june 2007 (exact date reported) with the 2nd dose of HPV 6 11 16 18 VLP(lot# vaccine not reported). the patient has not received her third dose of the HPV 6 11 16 18 VLF vaccine. the patient did receive unspecified medical attention and at the time of this report. the patient had not recovered.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on 17-DEC-2007 was vaccinated with the first dose of GARDASIL. Concomitant vaccine therapy included diphtheria toxoid (-) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer not specified). A few seconds after the vaccination with GARDASIL, the patient fainted. She recovered after 15 minutes. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported), who in the summer of 2007 was vaccinated with a dose of GARDASIL (lot # not reported). Following the vaccination, the patient visited an urgent care center, and was diagnosed with cellulitis at injection site (details not reported). Treatment included an unspecified antibiotic. At the time of this report, the outcome of cellulitis was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 22 year old female with a history of penicillin allergy and no pertinent medical history who on 17-DEC-2007 was vaccinated with a third dose of GARDASIL (lot# 659653/1448U) 0.5mL IM. Concomitant therapy included sulfamethoxazole/trimethoprim (BACTRIM) which the patient has been taking for more than one week. On 17-DEC-2007 a few hours her third dose of GARDASIL the patient developed a red rash on her chest, back and arms. At the time of reporting the patient was recovering. No other information was available. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 34 year old female who on 01-OCT-2007 was vaccinated with a dose of GARDASIL. There was no concomitant medication. On 02-OCT-2007, in the morning, the patient developed a "rash all over that was itching." As of 03-DEC-2007, the patient still had a residual rash but "not as bad as before." Unspecified medical attention was sought. At the time of report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia, Menstrual disorder
Clinical narrative: Information has been received from a nurse concerning a female (age not reported) who on unspecified dates was vaccinated with Gardasil.  The patient completed the full series of Gardasil with no events to speak of.  The patient called the practice to ask if the vaccine could have affected her menstruation because she is having difficulties in menstruation and abnormal bleeding.  The staff did not believe it was due to Gardasil.  The patient was not pregnant and is not pregnant.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a (approx) 20 year old female, with no known drug reactions/allergies or concomitant medication usage who in approximately November 2007 (exact date not reported), was vaccinated (route and site not reported) with the 2nd dose of Gardasil (lot # not reported).  Subsequently the following day, post vaccination, the patient developed a rash on her chest.  The patient reported the rash to the physician's office but no treatment was prescribed and no diagnostic labs were performed.  The patient recovered from the rash in an unspecified time period.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dry skin, Hair texture abnormal, Hunger, Immediate post-injection reaction
Clinical narrative: Information has been received from a consumer concerning her daughter (age not reported) with no pertinent medical history, drug reactions/allergies or concomitant medication usage who on 18-JUN-2007 and 15-Aug-2007 was vaccinated (route and site not reported) with the 1st and 2nd dose of the Gardasil (lot # not reported). The patient's mother stated that she picked up the 1st dose of Gardasil from the pharmacy and drove it to the doctor's office in 90F temperature with the air conditioning on and waited for about 1 hour at room temp at the doctor's office for the vaccine to be administered. On 18-JUN-2007, post vaccination, the patient experienced pain immediately after vaccination that lasted up to 2 weeks. The patient was unable to exercise for 1 week post vaccination. The patient stated that the pain was so intense that she felt like crying. The patient developed swelling near injection site, dry skin, dry hair after the 1st dose was administered. The patient also felt very hungry for 1 week after the 1st dose and believed she gained 5 lbs. The patient's mother stated that she picked up the 2nd dose of Gardasil from the pharmacy and stored it in her refrigerator (temp unknown) for 2 days before taking it to the doctor's office. On 15-AUG-2007, post vaccination for the 2nd dose, the patient experienced pain after vaccination that lasted up to 2 weeks. The patient received unspecified medical attention, no diagnostic test were performed. The patient recovered 2 weeks after each vaccination. In follow-up, the vaccination nurse was unable provide no additional information. This is one of several reports from the same source. The reporter stated that the patient had a few friends (number not specified) who received Gardasil and they all complained of pain on the injection arm. One friend still has pain when she gets tapped around the injection area. The friend was injected in June 2007. No additional information is expected.