chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Flushing, Headache, Rosacea
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on 10-DEC-2008 was vaccinated with her third dose of GARDASIL. The patient since 10-DEC-2008 had rosacea on the face that was worse in the evening. On 10-DEC-2008 later evening the patient had a bad headache, flushed face and achy joints. The patient had visited physician's office for medical attention. Follow-up information has been received from the nurse that the patient was vaccinated with her first dose of GARDASIL (lot # 659962/1740U) on 30-MAY-2008. The patient was vaccinated with her second dose of GARDASIL (lot # 659964/1978U) on 05-AUG-2008. The patient was vaccinated with her third dose of GARDASIL (lot # 660616/0570X) on 10-DEC-2008. The nurse stated that no labs were performed. A physician may ask if there was any correlation of rosacesa and GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with a dose of GARDASIL (dose, route and lot number not reported).  The consumer reported that her daughter had experienced HPV infections after she had received a dose of GARDSIL.  It was not specified if the patient sought medical attention.  This is one of two reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a nurse concerning a female patient who on unspecified dates was vaccinated with the first and the second 0.5 mL doses of GARDASIL. "Within a day" after receiving the first and second dose of GARDASIL, the patient experienced fatigue for about a week and then the patient recovered. The patient sought unspecified medical attention. 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 unspecified date was vaccinated with a 0.5 ml dose of GARDASIL (Lot # not reported).  Dose of the series was unknown.  It was reported that the patient fainted after receiving GARDASIL.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Rash
Clinical narrative: Information has been received from a Medical Assistant concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergy who on 23-DEC-2008 was vaccinated with first dose of GARDASIL (Lot # 661703/0651X) 0.5ml, intramuscularly. On 23-FEB-2009 she received second dose of GARDASIL (Lot # 661703/0651X) 0.5ml, intramuscularly. There was no concomitant medication. On 24-FEB-2009 the patient experienced "rash" on both of her elbows and headache. There were no Laboratory Diagnostics Studies Performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Migraine, Nausea, Photophobia, Presyncope
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 year old female with allergic rhinitis who on 26-Jan-2009 was vaccinated with the first dose of GARDASIL IM 0.5ml (lot# 651952/ 1129X). Concomitant therapy included NASONEX. On 26-Jan-2009 evening the patient developed a fever of 101.5 degrees F. a migraine-like headache, nausea, light sensitivity. She mentioned that the patient "almost pass out every time she stood up". There was no itching or hives noted. On an unknown date, the patient recovered from the events. The nurse mentioned that the patient's mother has declined to allow additional doses of GARDASIL for her daughter. The patient sought medical attention from her mother. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 year old female with allergic rhinitis who on 26-Jan-2009 was vaccinated with the first dose of GARDASIL IM 0.5ml (lot# 651952/ 1129X). Concomitant therapy included NASONEX. On 26-Jan-2009 evening the patient developed a fever of 101.5 degrees F. a migraine-like headache, nausea, light sensitivity. She mentioned that the patient "almost pass out every time she stood up". There was no itching or hives noted. On an unknown date, the patient recovered from the events. The nurse mentioned that the patient's mother has declined to allow additional doses of GARDASIL for her daughter. The patient sought medical attention from her mother. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Erythema, Lip swelling, Paraesthesia oral
Clinical narrative: Information has been received from a physician concerning a 21 year old female with Raynaud's syndrome and hypertension who on 26-FEB-2009, at 9:40 AM, was vaccinated with the second 0.5ml dose of GARDASIL. Concomitant therapy included DIFLUCAN, ALLEGRA, albuterol, hypertension medications and an unspecified beta-blocker. On 26-FEB-2009, at 16:00 at work, the patient felt tingling of her lips. The patient went to bed and had "terrible sleep" that night. On 27-FEB-2009 the patient woke up with periorbital redness, swollen lips, swollen nose ("like Bozo the clown"), shortness of breath and chest pain. The patient also had a periorbital itching. The physician instructed the patient to take BENADRYL. At the time of this report, the patient's adverse events improved, the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Swelling face
Clinical narrative: Information has been received from a physician concerning a 21 year old female with Raynaud's syndrome and hypertension who on 26-FEB-2009, at 9:40 AM, was vaccinated with the second 0.5ml dose of GARDASIL. Concomitant therapy included DIFLUCAN, ALLEGRA, albuterol, hypertension medications and an unspecified beta-blocker. On 26-FEB-2009, at 16:00 at work, the patient felt tingling of her lips. The patient went to bed and had "terrible sleep" that night. On 27-FEB-2009 the patient woke up with periorbital redness, swollen lips, swollen nose ("like Bozo the clown"), shortness of breath and chest pain. The patient also had a periorbital itching. The physician instructed the patient to take BENADRYL. At the time of this report, the patient's adverse events improved, the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female under 18 years old with no pertinent medical history who on 18-FEB-2009 was vaccinated with her first dose of GARDASIL (lot number, route and site not reported).  There was no concomitant medication.  On approximately 20-FEB-2009, 2-3 days after receiving vaccination the patient experienced syncope and went to the emergency room.  Electroencephalography (EEG) and neuro-consult were performed with no result reported.  The patient recovered from syncope after treating and was released from the emergency room on the same day.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with a dose of GARDASIL (dose, route and lot number not reported).  The consumer reporter that her daughter had experienced HPV infections after she had received a dose of GARDASIL.  At the time of the report the outcome of the patient was unknown.  It was not specified if the patient sought medical attention.  This is one of two reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of GARDASIL (Lot# not reported).  After receiving the dose of GARDASIL, the patient had fainted.  The outcome of adverse event was not reported.  It was not reported whether the patient sought medical attention.  This was one of several reports from the same source.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Muscular weakness, Neurological examination normal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female patient with no medical history and drug reactions who on 26-FEB-2009 was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number 0947X, site not reported).  There was no concomitant medication.  The patient developed muscle weakness radiating from her right arm to the right legs two hours after vaccination.  The patient stated that the muscle weakness began radiating to left side.  She was sent to the neurologist on 26-FEB-2009.  An unspecified neurological exam was negative for findings.  On 27-FEB-2009, the patient recovered from the event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with the second dose of GARDASIL 0.5 mL.  About an hour after receiving the vaccine, the patient experienced an episode of where her heart was racing and a shortness of breath.  The patient's outcome was unknown.  The patient sought unspecified medical attention.  Additional information has been requested. Follow up information has been received from the nurse practitioner concerning the female patient who on 01-OCT-2008 was vaccinated with the second dose of GADASIL (lot number 659184/0843X) 0.5 ml. Later in the day of vaccination, not necessarily an hour, the patient experienced the episode of her heart was racing and a shortness of breath. The adverse event was not reported to the nurse practitioner until the patient went to the office for the third dose of GARDASIL, which was not given. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Meconium in amniotic fluid
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female who on 14-JAN-2008 was vaccinated intramuscularly with first 0.5mL vaccine (lot number 659653/1448U).  Concomitant therapy included NUVARING.  On 24-MAR-2008 the patient was vaccinated intramuscularly with the second dose of GARDASIL (lot number 658556/1060U).  Subsequently, she became pregnant.  The patient was hospitalized for delivery.  On 16-JAN-2009 the patient delivered a baby boy who was 9 pounds and 4 ounces with APGAR of 9 and 9.  The reporter mentioned that during labor there was "meconuim staining to the amniotic fluid".  On 26-FEB-2009, the patient received the third dose of GARDASIL vaccine during a postpartum visit.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Infectious mononucleosis
Clinical narrative: Information has been received from a physician's assistant concerning an approximately 17 year old female patient who was vaccinated with the first dose of GARDASIL (lot # not reported).  Subsequently the patient experienced a headache and developed mononucleosis.  Patient received the second dose of GARDASIL (lot # not reported) and subsequently experienced a headache and developed mononucleosis.  Patient sought unspecified medical attention with the physician assistant.  Patient already completed the GARDASIL series.  Patient's present status is unknown.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Gastroenteritis viral, Injection site rash, Malaise, Myalgia
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter, with no known drug reaction/allergies and no pertinent medical history, who on 26-AUG-2008, was vaccinated with the first of GARDASIL and on unspecified dates, was vaccinated with the second dose and third dose of GARDASIL.  There was no concomitant medication.  The reporter stated that her daughter started having side effects after getting the second dose of the GARDASIL vaccine.  On 19-FEB-2009, the patient experienced nausea, rash at the injection site, abdominal pain, vomiting, muscle pain, weakness and complained of she felt sick all the time.  The consumer stated that "she did seek medical attention and they keep telling it is a stomach virus".  At the time of the report, the patient had not recovered.  Additional information has been requested.  3/23/09 Received vaccine & PCP medical records of 12/4/08-2/24/2009. FINAL DX: none provided Records reveal patient experienced cold s/s of cough, fatigue, fever, nasal congestion, sore throat & wheezing on 12/4 & had sick family member. Dx w/acute nasopharyngitis & cerumen impaction.  RTC 2/19/09 for routine GYN exam & HPV #2.  RTC 2/20 w/colicky abdominal pain x 1 day.  Exam revealed lower abdominal/pelvic pain thought to be premenstrual as due for depoprovera following wk.  RTC 2/24 w/continued abdominal pain.  No further records available.  3/23/09 Link w/342211.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter, with no known drug reaction/allergies and no pertinent medical history, who on 26-AUG-2008, was vaccinated with the first of GARDASIL and on unspecified dates, was vaccinated with the second dose and third dose of GARDASIL.  There was no concomitant medication.  The reporter stated that her daughter started having side effects after getting the second dose of the GARDASIL vaccine.  On 19-FEB-2009, the patient experienced nausea, rash at the injection site, abdominal pain, vomiting, muscle pain, weakness and complained of she felt sick all the time.  The consumer stated that "she did seek medical attention and they keep telling it is a stomach virus".  At the time of the report, the patient had not recovered.  Additional information has been requested.  3/23/09 Received vaccine & PCP medical records of 12/4/08-2/24/2009. FINAL DX: none provided Records reveal patient experienced cold s/s of cough, fatigue, fever, nasal congestion, sore throat & wheezing on 12/4 & had sick family member. Dx w/acute nasopharyngitis & cerumen impaction.  RTC 2/19/09 for routine GYN exam & HPV #2.  RTC 2/20 w/colicky abdominal pain x 1 day.  Exam revealed lower abdominal/pelvic pain thought to be premenstrual as due for depoprovera following wk.  RTC 2/24 w/continued abdominal pain.  No further records available.  3/23/09 Link w/342211.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain lower
Clinical narrative: Information has been received from a consumer concerning her 22 year old daughter, with no known drug reaction/allergies and no pertinent medical history, who on 26-AUG-2008, was vaccinated with the first of GARDASIL and on unspecified dates, was vaccinated with the second dose and third dose of GARDASIL.  There was no concomitant medication.  The reporter stated that her daughter started having side effects after getting the second dose of the GARDASIL vaccine.  On 19-FEB-2009, the patient experienced nausea, rash at the injection site, abdominal pain, vomiting, muscle pain, weakness and complained of she felt sick all the time.  The consumer stated that "she did seek medical attention and they keep telling it is a stomach virus".  At the time of the report, the patient had not recovered.  Additional information has been requested.  3/23/09 Received vaccine & PCP medical records of 12/4/08-2/24/2009. FINAL DX: none provided Records reveal patient experienced cold s/s of cough, fatigue, fever, nasal congestion, sore throat & wheezing on 12/4 & had sick family member. Dx w/acute nasopharyngitis & cerumen impaction.  RTC 2/19/09 for routine GYN exam & HPV #2.  RTC 2/20 w/colicky abdominal pain x 1 day.  Exam revealed lower abdominal/pelvic pain thought to be premenstrual as due for depoprovera following wk.  RTC 2/24 w/continued abdominal pain.  No further records available.  3/23/09 Link w/342211.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Gastroenteritis viral, Injection site rash, Malaise, Myalgia
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history and no known drug allergies or reactions who on 26-AUG-2008 was vaccinated with the first dose of HPV intramuscularly (lot # not provided).  On 19-FEB-2009 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL (lot # 660553/0070X).  Concomitant therapy included DEP0-PROVERA).  On 20-FEB-2009 ("the day after receiving the second dose"), the patient experienced lower abdominal pain.  No lab diagnostics studies were performed.  At the time of reporting, the patient's lower abdominal pain persisted.  The patient was seen by the nurse practitioner.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history and no known drug allergies or reactions who on 26-AUG-2008 was vaccinated with the first dose of HPV intramuscularly (lot # not provided).  On 19-FEB-2009 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL (lot # 660553/0070X).  Concomitant therapy included DEP0-PROVERA).  On 20-FEB-2009 ("the day after receiving the second dose"), the patient experienced lower abdominal pain.  No lab diagnostics studies were performed.  At the time of reporting, the patient's lower abdominal pain persisted.  The patient was seen by the nurse practitioner.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain lower
Clinical narrative: Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history and no known drug allergies or reactions who on 26-AUG-2008 was vaccinated with the first dose of HPV intramuscularly (lot # not provided).  On 19-FEB-2009 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL (lot # 660553/0070X).  Concomitant therapy included DEP0-PROVERA).  On 20-FEB-2009 ("the day after receiving the second dose"), the patient experienced lower abdominal pain.  No lab diagnostics studies were performed.  At the time of reporting, the patient's lower abdominal pain persisted.  The patient was seen by the nurse practitioner.  Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Off label use
Clinical narrative: Information has been received from a consumer concerning her son with no pertinent medical history, no drug reaction/allergies, who on unspecified dates was vaccinated with two doses of GADRASIL. There was no concomitant medication. The reporter stated that her son was prescribed by physician to get GARDASIL and that her son never completed the GARDASIL series. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: Information has been received from a 26 year old registered nurse, with no known medical history and drugs allergies, who two weeks ago was vaccinated with a first dose of GARDASIL intramuscularly into the left deltoid.  There was no concomitant medication.  Two weeks ago she had experienced severe injection site pain that had persisted and even intensified.  She saw her primary physician for treatment.  She had been treating with rest and ibuprofen.  The pain had restricted movement in her left arm but not disabling.  No laboratories studies performed.  The patient sought medical attention through her primary physician.  The patient recovered on an unspecified date.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations
Clinical narrative: Information has been received initially from a registered pharmacist who reported the pharmacy technician's daughter was given the third dose of GARDASIL on October 2008.  The technician's daughter after reported a "racing heart".  The caller stated that the patient was reporting that when she exercises her "heart goes really fast".  It was reported that the patient had not recovered at the time of the report.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a consumer concerning a female who was vaccinated with GARDASIL (Lot # not provided).  After receiving GARDASIL, the patient got sick.  The outcome of adverse event was not reported.  It was not reported whether the patient sought medical attention.  This was one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a consumer concerning a female who was vaccinated with GARDASIL (Lot # not provided).  After receiving GARDASIL, the patient got sick and was hospitalized.  The outcome of adverse event was not reported.  It was not reported whether the patient sought medical attention.  This was one of several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Headache, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL (Lot # not reported).  The patient experienced headaches after first and second dose of GARDASIL.   The patient decided to stop therapy.  The outcome of adverse event was not reported.  It was reported that the patient sought unspecified medical attention.  This was one of several reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Nausea, Pruritus, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a health professional concerning a patient who on 18-FEB-2009 was vaccinated with the first dose of GARDASIL. In February 2009, the patient experienced fever, nausea, vomiting, itching and rash. It was reported that the patient would not continue series. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain, Nausea, Neurological examination normal
Clinical narrative: Information has been received from a physician concerning a 20 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 08-JAN-2009 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 661046/0546X).  There was no concomitant medication.  It was reported that on 08-JAN-2009 after receiving the first dose of GARDASIL, the patient experienced dizziness, nausea and pain at the injection site.  On 08-JAN-2009, the patient's vital signs after receiving GARDASIL were pulse 88, blood pressure 114/62, and neurological checks were within normal limits.  It was reported that on an unknown date, after injection was given, the patient had gone to the emergency room due to her reactions.  It was reported that she was given a lotion to apply to the injection site on her right arm.  As of 25-FEB-2009 it was unknown if the patient continued to get the GARDASIL vaccine and she has recovered from the dizziness, nausea and pain at the injection site.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Induced abortion failed, Ultrasound abdomen normal
Clinical narrative: Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 19 year old multiracial female with no history of pregnancies and no significant past medical history or concurrent medical conditions who on 18-SEP-2008 was vaccinated with the first dose of GARDASIL (lot #: 0947X).  It was reported that the patient was pregnant at the time of vaccination.  The patient's date of last menstrual period was 05-SEP-2008, estimated delivery date was 11-JUN-2009.  0n 31-OCT-2008, the patient took one dose of MIFEPROSTONE and MISOPROSTOL for attempted abortion.  On 10-FEB-2009, ultrasound was performed to assess anatomy and confirm dates, which revealed that the patient was doing well and was at 22 weeks gestation.  The estimated date of confinement (EDC) was 12-JUN-2009.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Headache, No reaction on previous exposure to drug, Vomiting
Clinical narrative: Information has been received from a consumer concerning a 15 year old female patient who started therapy in August 2009 with the first dose of GARDASIL. The caller reported that her granddaughter received all three doses of GARDASIL and was fine after the first and second dose. She received the third dose two weeks ago (January 2009) (lot # not reported) and "yesterday" (approximately 08-Feb-2009) woke up with a headache, stomach ache and threw up. No diagnostic tests or laboratory work was performed. The outcome was not reported. A product quality complaint was not involved. No further information was provided.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Coeliac disease
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female who on unknown date was vaccinated with two doses of GARDASIL from another provider and was diagnosed with experienced celiac disease.  At the time of reporting, 25-FEB-2009, the patient's celiac disease persisted.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Influenza like illness, Malaise, Nausea, Retching
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with endometriosis who on unspecified dates was vaccinated with the first two doses GARDASIL (lot number not specified). There was no concomitant medication. The patient experienced nausea, "gagging", flu-like symptoms and felt miserable 2 weeks after she received the second dose of GARDASIL. At the time of reporting, 2-Feb-2009, the patient had recovered. Additional information has been requested.  09/04/2009 Received vaccine & PCP medical records. FINAL DX: arthralgia; lymphadenopathy w/u benign; endometriosis; dyspepsia/gastritis. Records reveal patient experienced LLQ pain radiating into groin w/lymphadenopathy x approx 1 year; gagging in AM; heavy menstruation w/clots when seen 12/12/08.  12/16/08 Referred to Rheum when ANA was elevated;referred  to surgeon to eval lymphadenopathy; referred for CT abd/pelvis to eval LLQ pain.  Rheum consult of 8/20/09 reveals patient w/joint pain; abdominal pain & nausea x approx 2 yrs, worse at night & disturbs sleep; fatigue.  Had been dx w/endometriosis & on BCPs which helped symptoms.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Fatigue, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with endometriosis who on unspecified dates was vaccinated with the first two doses GARDASIL (lot number not specified). There was no concomitant medication. The patient experienced nausea, "gagging", flu-like symptoms and felt miserable 2 weeks after she received the second dose of GARDASIL. At the time of reporting, 2-Feb-2009, the patient had recovered. Additional information has been requested.  09/04/2009 Received vaccine & PCP medical records. FINAL DX: arthralgia; lymphadenopathy w/u benign; endometriosis; dyspepsia/gastritis. Records reveal patient experienced LLQ pain radiating into groin w/lymphadenopathy x approx 1 year; gagging in AM; heavy menstruation w/clots when seen 12/12/08.  12/16/08 Referred to Rheum when ANA was elevated;referred  to surgeon to eval lymphadenopathy; referred for CT abd/pelvis to eval LLQ pain.  Rheum consult of 8/20/09 reveals patient w/joint pain; abdominal pain & nausea x approx 2 yrs, worse at night & disturbs sleep; fatigue.  Had been dx w/endometriosis & on BCPs which helped symptoms.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 24 year old female patient who on 28-NOV-2008 was vaccinated with first dose of GARDASIL (Lot # not reported).  On 03-DEC-2008 the patient experienced flu like symptoms such as fever, body aches and headaches.  On 18-FEB-2009 the nurse called the patient to found out why she did not show up the second dose of GARDASIL and the patient mentioned the experienced and decided not to get the rest of the series.  There were no Laboratory Diagnostics Studies performed.  At the time on the report on 23-FEB-2009 the patient was recovered.  The patient did not seek medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician's assistant concerning her relative, a female who on an unspecified date was vaccinated with GARDASIL. It was reported that the patient thought she developed GUILLAN-BARRE after receiving GARDASIL. The patient sought unspecified medical attention. Upon internal review GUILLAN-BARRE was considered to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Hypoaesthesia, Pallor, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female student with no known medical history and drug allergies, who on 14-FEB-2009 at 10:00 was vaccinated with a second dose of GARDASIL (lot # 661766/0652X), intramuscularly into the right deltoid. Concomitant suspect therapy included hepatitis A vaccine (MSD) (lot # 658174/1297X), intramuscularly into the left deltoid on 14-FEB-2009. On 14-FEB-2009 at 10:00 after receiving the second dose of GARDASIL the patient became pale, and fainted for approximately 1-2 minutes. Blood pressure was 120/10. It was also reported that the patient was complaining of numbness in right arm. The patient also experienced fainting after the first dose of GARDASIL when she was 14 years old. No laboratories studies performed. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with three doses of GARDASIL (Lot # not reported). The patient experienced headaches after all three doses of GARDASIL. The outcome was not reported. It was reported that the patient sought unspecified medical attention. This was one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with allergy to AMOXICILLIN who in August 2008, was vaccinated with the first dose of GARDASIL (Lot # not provided), in OCT-2008, was vaccinated with the second dose of GARDASIL (Lot# not provided).  Concomitant therapy included MENACTRA which she received with the first dose of GARDASIL.  Then in the first week of November 2008, the patient started to have severe lower back pain.  Then the back pain progressed over the week with some tingling in her legs.  The patient then saw a physician who recommended physical therapy and to see a chiropractor.  The patient had a MRI which showed everything was fine.  The patient had been doing better with the physical therapy, but then two weeks ago the back pain started to bother her again.  The reporter was not sure if the back pain and tingling in the legs was related to GARDASIL, but she decided not to give the third GARDASIL at this point in time.  The patient was not recovered from back pain and tingling in her legs.  She went to the doctor, chiropractor, physical therapy, MRI.  This was one of several reports from the same source.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site scar
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female patient with no pertinent medical history and no known drug allergies or reactions who in October 2008 was vaccinated with the first dose of GARDASIL.  The patient had no problems with dose 1.  On an unspecified date the patient was vaccinated with the second dose of GARDASIL vaccine at a different facility.  Concomitant therapy included hormonal contraceptives (unspecified).  Subsequently the patient experienced scarring at the injection site.  There was a white ring at the injection site that was 2 and 1/2 centimeters in diameter and it looked like a "puncture scar".  There was no pain and no swelling.  No lab diagnostics studies were performed.  At the time of reporting, the patient's scarring at the injection site persisted.  The patient sought medical attention via office visit.  Additional information has been requested
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a nurse midwife concerning an unspecified number of patients who were vaccinated IM with the second dose 0.5ml dose of GARDASIL (lot number and site note reported). The patients had complained that the second dose hurt a lot more than the first. As  of the report time, the outcome of the event was not reported. The patients had sought medical attention in the office. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, Pain
Clinical narrative: Information has been received from a physician concerning several hundred patient who on unspecified dates were vaccinated with doses of GARDASIL (lot number, route and site not reported). It was reported that the products had been predrawn and stored in the refrigerator for up to one week. No adverse effect reported except"it always stings". As of this report time, the outcome was not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received form a physician concerning a female who was vaccinated with a 0.5 ml dose of GARDASIL. Subsequently the patient experienced a migraine. It was unknown what dose of series of GARDASIL vaccine migraine occurred after. No lot number was provided. At the time of reporting the patient was recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL. The patient experienced a rash "a few months after getting the first dose". The patient also developed a rash a few months after second dose of vaccine as well. It is unknown if the patient received her third shot or not. The patient  sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a consumer concerning her daughter who became ill after received her second dose of GARDASIL.  The consumer did not want to provide demographics nor explanation of the AE.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Vaginal lesion
Clinical narrative: Information has been received from a physician assistant student concerning a 16 year old female who on 06-JAN-2009 was vaccinated with first dose of GARDASIL.  There was no concomitant medication.  On 25-FEB-2009 she was seen in the physician's office and was found to have genital warts.  She and had two small warts in the inferior anus, lesions intravaginally and the entire area of perineal area covered with warts.  The patient was asymptomatic.  The patient admitted to having unprotected intercourse in mid December 2008.  The patient had not recovered from the event at the time of the report.  Lab studies performed included Papanicolaou test (results not reported).  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Hypomenorrhoea
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with no known medical history or drug allergies, who on 26-JUN-2008 or 28-JUN-2008 was vaccinated with a first dose of GARDASIL. The patient received a second dose of GARDASIL in July 2008 and a third dose of GARDASIL on 15-JAN-2009. It was also reported that the patient had a dose of hepatitis A vaccine on 15-JAN-2009. In July 2008 the patient started to have a light period, and since July 2007 she never had her menstrual period. No laboratories studies were performed. The patient sought medical attention through the health department. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received form a 23 year old female patient, with no known drug reaction/allergies and no pertinent medical history, who in January 2009, was vaccinated with her first dose of GARDASIL. Concomitant therapy included vitamins (unspecified). The consumer reported that she experienced hair loss since 3 weeks ago when she received her first dose of GARDASIL vaccine. At the time of the report, the patient was recovering. The patient spoke to her physician seeking for medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Pain
Clinical narrative: Information has been received from a consumer concerning her daughter (a 16 year old female) who in March 2008, was vaccinated with her first dose of GARDASIL.  About 24 hours after receiving the vaccine (March 2008), the patient felt like there was stakes going through her arms and legs for about 2 weeks after receiving the vaccine.  Caller stated it was intense pain and she had difficulty moving.  At the time of the report (23-FEB-2009) patient had not received the second or third dose.  It was reported that therapy with GARDASIL was discontinued in March 2008.  The patient was recovered about 2 weeks after receiving the vaccine.   The patient sought unspecified medical attention.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Gianotti-Crosti syndrome, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning her 20 year old daughter who was vaccinated with her third dose of GARDASIL (lot # not available).  On "Labor Day weekend of 2008" approximately 31-AUG-2008 the patient developed "Giannati-crosti syndrome" 6 to 7 months after the patient received her third dose of GARDASIL.  The patient had rashes on her feets, arms and face.  The nurse noted that the patient did not have any adverse events with the first and second dose of GARDASIL.  The patient had seen physician in office for medical attention.  At the time of reporting the patient was recovering from the adverse events.  Additional information has been requested.  6/17/09 ER records received DOS 11/22/07. Assessment: acute febrile illness, viral exanthem.  Patient presented with a fine raised red rash. Fever, nausea, decreased appetite.  6/19/09 Received Dermatology consult of 9/4/2008. FINAL DX: Gianotti-Crosti Syndrome REcords reveal patient experienced generalized itchy papular rash.  Had been seen in ER & tx w/steroid injection, oral antibiotics, benadryl & oral prednisone on 9/1.  Tx w/continued tapering steroids.  RTC if worsens.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Herpes simplex serology negative
Clinical narrative: Information has been received from a physician concerning a 38 year old female with no medical history or drug allergies who was intramuscularly vaccinated with the first, second and third 0.5 ml doses of GARDASIL (1st and 2nd lots #"0770X", 3rd lot #0573X) on 07-AUG-2008, 11-SEP-2008 and 03-FEB-2009, respectively.  The patient developed reactivation of genital warts a few days after receiving her third dose of GARDASIL.  She had negative culture for herpes.  Subsequently, the patient recovered from reactivation of genital warts on an unspecified date.  The patient visited family physician for medical attention.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a pharmacist concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergy who on approximately 16-FEB-2009 was vaccinated with first dose of GARDASIL (Lot # not reported).  There was no concomitant medication.  On approximately 16-FEB-2009 since vaccine was administered the patient experienced headache.  At the time on the report on 23-FEB-2009 the patient was not recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Nausea, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 17-FEB-2009 was vaccinated with the second dose of GARDASIL (Lot # 659655/0940X) intramuscularly into the left deltoid at 12:45. Secondary suspect therapy on 17-FEB-2009 included a second dose of hepatitis A virus vaccine inactivated (MSD) (Lot # 658174/1297X) intramuscularly into the right deltoid. It was reported that on 17-FEB-2009 at 13:00, the patient became pale and felt nauseated after receiving the second dose of GARDASIL for approximately 10 minutes. There were no laboratory tests performed. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female patient with allergy to sulfa and asthma and a history of "brachial plexus" who on 09-OCT-2008 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot #660557/0072X). It was given in the left gluteal region. On 20-FEB-2009 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL (lot # 661764/0650X). Concomitant therapy included hormonal contraceptives (unspecified), montelukast sodium, ZYRTEC, albuterol, VERAMYST and ADVAIR. On 20-FEB-2009 the patient experienced passed out while she was still in the office. No lab diagnostics studies were performed. On 20-FEB-2009, the patient regained consciousness and recovered. The patient sought medical attention in the office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, MEN
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history and no known drug allergies who on 20-FEB-2009 was vaccinated intramuscularly with a second 0.5 ml dose of GARDASIL (Lot # 654741/1208F). On the same day she also received a dose of secondary suspect vaccine, hepatitis B vaccine (manufacturer unknown) and a dose of concomitant  therapy, "meningitis vaccine" (manufacturer unknown). "Three minutes after administration of the second dose of GARDASIL", the patient fainted. She "quickly" recovered. No lab diagnostics studies were performed. It was reported that the lot number and date of administration of the first dose of GARDASIL were unknown. Unspecified medical attention was sought. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who was vaccinated with a 0.5 ml IM dose of GARDASIL. Subsequently ("within 1 day of receiving GARDASIL") the patient experienced a high fever (above 102.6F). Therapy with GARDASIL was discontinued. The patient sought medical attention via telephone. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blister, Headache, Influenza like illness, Rash
Clinical narrative: Information has been received from a consumer concerning her 16 year old grand daughter (patient) who on 08-JUN-2007 was vaccinated with a first dose of GARDASIL 0.5 mL and on 04-AUG-2007 was vaccinated with a second dose of GARDASIL.  There was no concomitant medication.  On approximately 08-JUN-2007 ("shortly after first dose") the patient experienced flu like symptoms.  She did not have much energy and a little rash.  After the second dose, the patient experienced headaches, a rash.  She broke out in "huge" blisters all over her back.  In September 2007, the patient recovered.  Third dose was never given.  The patient sought unspecified medical attention.  No further information is available.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Off label use
Clinical narrative: Information has been received from a physician concerning a health care provider's 20 year old son who was vaccinated with the second dose of GARDASIL on unspecified date.  In July 2008, the patient experienced headache after receiving the second dose of GARDASIL.  On unspecified date, he recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Local swelling, Oropharyngeal discomfort, Swelling face
Clinical narrative: Information has been received from a nurse concerning a 17-year-old female with no known relevant medical history nor drug allergy, who on 10-FEB-2009 was vaccinated IM with the first dose of 0.5 ml GARDASIL (lot # 661952/1129X) in her deltoid. There was no concomitant therapy. On 12-FEB-2009 the patient's mom called to office to seek medical attention concerning the patient's reaction that took place on 11-FEB-2009. The patient's face was described as "puffy from the neck up to her cheeks". The patient felt it was a little difficult to breathe and her throat "felt funny". She took BENADRYL 2 doses on 11-FEB-2009 and on 12-FEB-2009 she took CLARITIN. No laboratory test was performed. On an unspecified date, the patient recovered from the event. Her primary physician and school nurse felt the reaction was due to GARDASIL and recommended discontinuing the series. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Full blood count abnormal, Headache, Myalgia, Pain
Clinical narrative: Information has been received from a physician concerning a 16-year-old white female student, with no known relevant medical history nor drug allergy, who on 15-JAN-2007 was vaccinated IM in her left deltoid with the first dose of GARDASIL (lot # 653650/0697F).  Concomitant therapy included ALESSE, ASTELIN and RHINOCORT.  On 26-FEB-2007, the patient experienced headache and myalgia.  On 27-FEB-2007, her temperature was 101 degrees Fahrenheit.  Medical attention was sought and the events required ER/DR visit.  Laboratory test showed that all CBC and ESR were negative.  On 23-MAR-2007, the patient was vaccinated IM in her left deltoid with the second dose of GARDASIL (lot # 653650/0697F).  Subsequently on 24-MAR-2007, she experienced "ST" and headache.  On 26-MAR-2007, her temperature was of 101.5 degrees Fahrenheit, she also experienced bodyache.  The patient's outcome was unknown.  No further information is available.