chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Injection site nodule, Scan brain, Screaming
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2009. Information has been received from a nurse practitioner concerning a 17 year old female patient with no pertinent medical history and no known drug allergies who on 02-JUL-2008, was vaccinated with the first 0.5 ml IM dose of GARDASIL into her left arm. On 03-SEP-2008 the patient received the second 0.5 ml IM dose of GARDASIL into her left arm. There was no concomitant medication. On 04-SEP-2008 the patient experienced severe headaches. The patient was found by her mother in bed holding her head, hollering and thrashing. The patient was taken to the emergency room and was treated with MOTRIN. A head scan was performed and the result was benign. The headaches lasted for five days. The patient also had granuloma (also reported as a large lump) at the injection site. On approximately 08-SEP-2008 ("5 days after onset"), the patient recovered from adverse events. VAERS number: 340738, 340728. This is a consolidation of two reports concerning the same patient. This is one of several reports from the same source. Additional information has been requested. It has been determined that WAES # 0901USA01005 is a duplicate of WAES # 0901USA00374. Therefore, WAES # 0901USA01005 is being deleted from our files and the reports consolidated into WAES # 0901USA00374.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who on 06-MAY-2008 was vaccinated with GARDASIL intramuscularly 0.5 mL.  Subsequently the patient developed intermittent "aching" to her hips, knees and right ankle after vaccination.  The patient visited the office.  At the time of reporting, the patient's intermittent "aching" to her hips, knees and right ankle after vaccination persisted.  No further information was available.
Age: 45.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a 45 year old female patient who was vaccinated with two doses of GARDASIL vaccine (no lot number was provided). Subsequently the patient experienced unspecified problems. At the time of this report, the outcome is unknown. It is unspecified if the patient sought medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female who on unspecified dates was vaccinated with the first and the second dose of GARDASIL vaccine. Patient did not experience any problems. On 24-NOV-2008, the patient was vaccinated with the third dose of GARDASIL vaccine (lot number 661764/0650X)0.5 ml IM and experienced a lump in the injection site area shortly after on the same day. The lump was painful to touch. The patient sought medical attention, called office. The location of the lump was unspecified. The lump resolved on its own couple of weeks after received the third dose. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Dizziness, Pyrexia, Vision blurred
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female patient with no pertinent medical history and with allergic reaction to ERYTHROMYCIN who on 18-APR-2008 was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly.  There was no concomitant medication.  On 16-JUL-2008 the patient was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # 659439/1267U) intramuscularly.  It was reported that the patient has been having symptoms after receiving GARDASIL.  It was reported that the patient experienced dizziness and blurry vision in the office after receiving the second dose of GARDASIL.  The patient went home after the recovery.  It was reported that the patient has been having occasional fever and back pain since receiving the second dose of GARDASIL.  The patient was seen by the physician.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Computerised tomogram head, Headache, Headache, Hypoaesthesia
Clinical narrative: Information has been received from a doctor of pharmacist concerning a 17 year old female patient with no pertinent medical history and no known drug allergies/drug reactions, who completed her GARDASIL vaccine series "sometime" last year. Concomitant therapy included hormonal contraceptives (unspecified) and vitamins (unspecified). It was reported that about a month after completion of the series the patient began to develop "stabbing left hemisphere head pain and numbness to the left arm and leg. It was reported that the patient has continued to have biweekly "attacks" since the beginning of symptoms. At the time of reporting the patient had a blood work, head computed axial tomography and an magnetic resonance imaging of head done. All results were negative. At the time of the report the patient had not recovered. The patient sought medical attention with the neurologist. Additional information has been requested. Follow-up information received from the physician's office who reported that the 16-year-old female patient (previously reported at 17 years old) was experiencing headaches prior to receving the third dose of GARDASIL given in October 2008 (previously re ported as 2009, month unknown). Onset date of headaches and hypaesthesia was reported as November 2008 dose. The patient was seen by neurologist in late December/ early January and was diagnosed with migranines. The patient was not hospitalized and is currently doing fine. No further information is available.   3/16/09 Received Neuro medical records of 1/8-2/18/2009. FINAL DX: probable basilar migraine Records reveal patient experienced four spells of unconsciousness, pallor, slurred speech over several weeks preceded by blurred vision & seeing spots.  Has had frequent dizziness, right parietal pain, contralateral arm & leg tingling.  Referred for MRI & tx w/meds.  RTC 2/18 w/good response to meds.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Laboratory test normal, Migraine, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a doctor of pharmacist concerning a 17 year old female patient with no pertinent medical history and no known drug allergies/drug reactions, who completed her GARDASIL vaccine series "sometime" last year. Concomitant therapy included hormonal contraceptives (unspecified) and vitamins (unspecified). It was reported that about a month after completion of the series the patient began to develop "stabbing left hemisphere head pain and numbness to the left arm and leg. It was reported that the patient has continued to have biweekly "attacks" since the beginning of symptoms. At the time of reporting the patient had a blood work, head computed axial tomography and an magnetic resonance imaging of head done. All results were negative. At the time of the report the patient had not recovered. The patient sought medical attention with the neurologist. Additional information has been requested. Follow-up information received from the physician's office who reported that the 16-year-old female patient (previously reported at 17 years old) was experiencing headaches prior to receving the third dose of GARDASIL given in October 2008 (previously re ported as 2009, month unknown). Onset date of headaches and hypaesthesia was reported as November 2008 dose. The patient was seen by neurologist in late December/ early January and was diagnosed with migranines. The patient was not hospitalized and is currently doing fine. No further information is available.   3/16/09 Received Neuro medical records of 1/8-2/18/2009. FINAL DX: probable basilar migraine Records reveal patient experienced four spells of unconsciousness, pallor, slurred speech over several weeks preceded by blurred vision & seeing spots.  Has had frequent dizziness, right parietal pain, contralateral arm & leg tingling.  Referred for MRI & tx w/meds.  RTC 2/18 w/good response to meds.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female patient who on 15-MAY-2008 was vaccinated with the first dose of GARDASIL.  On 29-DEC-2008 the patient was vaccinated with the third dose of GARDASIL (Lot # 660620/0571X).  It was reported that the patient developed a rash 6 hours after the third dose of GARDASIL was given.  The patient was recovered.  It was reported that patient's mother called physician's office.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Culture positive, HIV antibody negative, Herpes zoster, Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (lot no. 659180/1758U) 0.5 ml, IM. On 29-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (lot no. 660387/1967U) 0.5 ml, IM and on 24-NOV-2008 with the third dose of GARDASIL vaccine (lot no. 655604/0052X) 0.5 ml, IM. The physician reported that the patient developed Zoster 7 to 10 days after administration of her first and second dose of GARDASIL vaccine. The physician reported that the first outbreak of Zoster was below her breast bone at the end of her sternum. It was 3 inches wide. The patient had severe pain and some itchiness. The physician did not know the location of her second outbreak because the physician did not examine the patient but rather treated her over the phone. The patient was treated with VALTREX and ADVIL both times. The second outbreak required to be treated with a second course of VALTREX. Cultured cessions from the first outbreak confirmed Varicella Zoster virus. Additional information has been requested.  Follow up information has been received from the physician concerning the female patient with no illness at the timf of vaccination and with no previous medical history and allergies reported. who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL and concomitantly at the same time with the first dose of MENACTRA (Lot number U2331AA) IM into the right deltoid and with the first dose of  ADACEL (Lot number C2889AA) IM into the left deltoid. One week after the vaccination, the patient developed a rash. On 04-JUN-2008, a VZV AG, DFA was performed, the specimen source was a vesicular lesion abdomen, it was detected varicella zoster virus and the patient's diagnosis was shingles. On 10-JUN-2008, the patient recovered.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Platelet disorder, Pruritus, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL vaccine (lot no. 659180/1758U) 0.5 ml, IM. On 29-JUL-2008 was vaccinated with the second dose of GARDASIL vaccine (lot no. 660387/1967U) 0.5 ml, IM and on 24-NOV-2008 with the third dose of GARDASIL vaccine (lot no. 655604/0052X) 0.5 ml, IM. The physician reported that the patient developed Zoster 7 to 10 days after administration of her first and second dose of GARDASIL vaccine. The physician reported that the first outbreak of Zoster was below her breast bone at the end of her sternum. It was 3 inches wide. The patient had severe pain and some itchiness. The physician did not know the location of her second outbreak because the physician did not examine the patient but rather treated her over the phone. The patient was treated with VALTREX and ADVIL both times. The second outbreak required to be treated with a second course of VALTREX. Cultured cessions from the first outbreak confirmed Varicella Zoster virus. Additional information has been requested.  Follow up information has been received from the physician concerning the female patient with no illness at the timf of vaccination and with no previous medical history and allergies reported. who on 20-MAY-2008 was vaccinated with the first dose of GARDASIL and concomitantly at the same time with the first dose of MENACTRA (Lot number U2331AA) IM into the right deltoid and with the first dose of  ADACEL (Lot number C2889AA) IM into the left deltoid. One week after the vaccination, the patient developed a rash. On 04-JUN-2008, a VZV AG, DFA was performed, the specimen source was a vesicular lesion abdomen, it was detected varicella zoster virus and the patient's diagnosis was shingles. On 10-JUN-2008, the patient recovered.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Smear cervix normal
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter who on 09-APR-2007 was vaccinated with the first dose of GARDASIL.  On 08-JUN-2007, the patient was vaccinated with the second dose of GARDASIL and on 15-OCT-2007 with the third dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified) and ALDACTONE tablets.  On 12-MAR-2008, was performed a papanicolau test with abnormal results.  On 16-SEP-2008, was performed her last PAP test with normal results.  This is one of several reports provided by the same source.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Drug exposure during pregnancy, Headache, Nausea
Clinical narrative: Information has been received from a 24 year old female patient, for GARDASIL vaccine, a Pregnancy Registry product concerning herself with no pertinent medical history and no known drug allergy who in September 2008, was vaccinated with the second dose of GARDASIL vaccine. Concomitant therapy included INFLUENZA VIRUS vaccine (unspecified). In approximately 06-DEC-2008 ("a month ago"), the patient was pregnant. LMP was approximately 06-DEC-2008 and estimated delivery date was 12-Sep-2009. The patient also experienced feeling nauseous and headache. Therapy with GARDASIL vaccine was discontinued. No lab diagnostics studies were performed. The patient did not seek medical attention. At the time of reporting, the patient did not recover yet. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site reaction, Rash macular
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no medical history or drug allergy who on 05-JAN-2009 was vaccinated with the third dose of GARDASIL (lot # 0544X), 0.5ml. IM.  There was no concomitant medication.  The patient developed a rash in the area of the injection site almost immediately after receiving her third dose of GARDASIL vaccine on 05-JAN-2009.  The rash, which was red and blotchy, extended from the deltoid area to the elbow but it was not known whether right or left arm involved.  The patient was given BENADRYL and the rash resolved by 06-JAN-2009.  The patient sought attention by office visit.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Syncope, Syncope
Clinical narrative: Information has been received from 2 nurses concerning a 17 year old female with a history of fainting who on 30-DEC-2008 was vaccinated with the first dose of GARDASIL. The patient fainted within an hour after receiving the vaccine. The patient fainted 3 times. The patient recovered that same day and went home. Lot# was not available. Follow-up information was received from a registered nurse (RN) concerning the 17 year old female patient who came to office and was vaccinated intramusculary in the left deltoid with the first dose of GARDISIL (6650555/0279X) on 30-DEC-2008. There was no illness at the time of vaccination. Subsquently the patient experienced a syncopal episode (less than 15 seconds), and it occured twice more. The patient was able to walk out of the office finally after aproximately 1.5 hours. BP: 114/72 mmHg (standing level) 104/60 mmHg; o2 sat, 98%. The patient recovered on 10-DEC-2008. No relevant diagnostic tests or laboratory tests were performed. The patient sought medical attention by visiting the nurse and physician's office. No further information was available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Urticaria
Clinical narrative: Information has been received from a physician assistant (P.A.)concerning an 18 year old female with reactions to vaccines who was vaccinated with a dose of GARDASIL (lot# 660557/0072X). On 30-DEC-2008 the patient broke out in hives on the face, "abs", arms, and torso. The patient was given BENADRYL in the office and within 15 minutes, the hives were gone. The patient was sent home with a Prednisone prescription. The patient recovered on 30-DEC-2008. It was unspecified which dose the patient had a reaction from therefore it is unknown which dose is the lot number provided. The patient sought medical attention at the physician's office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009. Follow up information was received from a Physician's assistant (P.A.) concerning the 18 year old female patient with penicillin allergy and allergic rhinitis who on 30-DEC-2008 2:00 pm was vaccinated intramuscularly in the left arm with the second dose of GARDASIL. There was no illness at the time of vaccination. On 10-DEC-2008 at 2:05 pm the patient had extensive urticaria including face without angioedema approximately 5 minutes following administration. The patient felt faint. She had no loss of consciousness, dysphagia, or shortness of breath. The patient was given BENADRYL, IM and advised to rest 15 minutes in office. After that, urticaria subsided and the patient was released home with prescription for prednisone (po) and advised to continue BENADRYL (OTC, IM). The patient was advised to emergency room if symptoms worsen. No relevant diagnostic tests or laboratory data was collected. The patient was recovered on 30-DEC-2008. Information was received from a medical assistant reported the patient's name and the medication was GARDASIL. She did not have any additional information to provide. The reporter considered the patient's experiences to be other important medical events. The patient sought medical attention at the physician's office. No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Vomiting in pregnancy
Clinical narrative: Information has been received from a 24 year old female medical assistant who in December 2008, was vaccinated with a second dose of GARDASIL, 0.5ml.  At the time of reporting the patient was pregnant.  Follow-up information has been received from the patient concerning herself whose LMP was sometime in November 2008 and due date was sometimes in the beginning of September 2009.  This was her third pregnancy and she has 2 living children.  The patient said everything felt fine so far, except for the morning sickness.  The patient saw a new OB, who told her everything was fine.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning an 17 year old female who on 02-JAN-2009 was vaccinated with the first dose of GARDASIL. Within a couple of hours the patient became dizzy. Eight hours later she experienced nausea and vomiting. She also had a rash that lasted 2 to 3 days. At the time of reporting, the patient recovered from the events. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Full blood count, Protein urine present, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female with urinary frequency, obesity and hypertension, a history of tonsillitis and no drug allergies who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL on 16-JUL-2007 and 22-DEC-2008 (1st lot # 656372/0243U, 2nd lot # 651044/0548X), respectively.  Concomitant therapy included YASMIN.  On 22-DEC-2008 the patient had a negative early pregnancy test and on 29-DEC-2008 it was positive.  It was also reported that the urine analysis positive for protein, and a complete blood cell count was performed.  No other adverse effects were reported.  The patient was seen for medical attention.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning an 11 year old female who in August 2007, was vaccinated with the first dose of GARDASIL. "The same day of the vaccination", after receiving the vaccination, the patient passed out in the office. On unspecified date, the patient recovered. Follow up information was received from someone at the physician's office. The person reported "this was over a year ago." She also reported "the patient passed out with the first dose". The administering nurse no longer works at the office and no one can recall the patient. I t was reported that the patient recovered within minutes of injection. No further information was available.
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Information has been received from a registered nurse, concerning a female patient, who on an unspecified date was vaccinated with GARDASIL. The registered nurse mentioned the patient developed a fever and Cellulitis like reaction after receiving her first of HPV vaccine. The patient sought medical attention and was seen at the physician's office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Hot flush, Paraesthesia
Clinical narrative: Information has been received from a registered nurse, concerning a female patient, who on an unspecified date was vaccinated with GARDASIL ,0.5ml intra muscularly. The registered nurse reported that the patient developed tingling in both her hands, chills and hot flashes after receiving the vaccine. It was not specified by the registered nurse when the symptoms developed or how many doses of the vaccine the patient had received. The registered nurse mentioned that "the patient may have been coming down with the flu at this time." The patient sought medical attention through a telephone call. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from an educator concerning a 7th to 9th grade female student, who "within the last 12 months" was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL. The patient may have been vaccinated in combination with other vaccines that was needed to go back into middle school. "Within the last 12 months", when she got vaccinated, the patient felt "excruciating" pain. Subsequently, the patient had recovered at the time of vaccination. The reporter did not know if the patient experienced the adverse event with their 1st, 2nd or 3rd dose. The patient sought unspecified medical attention. This is one of several cases from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from an educator concerning a 7th to 9th grade female student, who "within the last 12 months" was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL. The patient may have been vaccinated in combination with other vaccines that was needed to go back into middle school. "Within the last 12 months", when vaccinated, the patient almost fainted. Subsequently, the patient had recovered at the time of vaccination. The reporter did not know if the patient experienced the adverse event with their 1st, 2nd or 3rd dose. The patient sought unspecified medical attention. This is one of several cases from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from an educator concerning a 7th to 9th grade female student, who "within the last 12 months" was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL. The patient may have been vaccinated in combination with other vaccines that was needed to go back into middle school. "Within the last 12 months", when vaccinated, the patient fully fainted. Subsequently, the patient had recovered at the time of vaccination. The reporter did not know if the patient experienced the adverse event with their 1st, 2nd or 3rd dose. The patient sought unspecified medical attention. This is one of several cases from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female with allergy to latex who was vaccinated with GARDASIL. Concomitant therapy included penicillin (unspecified). 4 to 6 hours later the patient broke out in hives. The reporter was  uncertain if hives were related to the GARDASIL. The patient sought unspecified medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from a 27 year old female patient who on 08-OCT-2008 was vaccinated with a first dose of GARDASIL, when she was already 27 years old; the patient experienced headache and some fever. The caller cannot get the second and the third dose of GARDASIL because her insurance will not cover it because of her age. The patient did not seek medical attention. The patient recovered on an unspecified date. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, VARCEL
Symptoms: Amnesia, Back pain, Body temperature increased, Depression, Mood swings
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no known medical history and allergies, who on 10-JUN-2008 was vaccinated with a first dose of GARDASIL.  On 10-JUN-2008 the patient experienced fever of 102 for three to four days.  She also started getting depressed, and she begun having mood swings, memory loss, achy back and muscle pain.  After she received the second dose of GARDASIL, she came down with a fever of 103 and the symptoms continued and had not improved.  There were no laboratory diagnostics performed.  The patient did not seek medical attention.  At the time of this report the patient had not recovered.  Follow up information received on 19-JAN-2009 stated that a phone call was received from the reporter, she mentioned that a physician did not administered the GARDASIL vaccine, a nurse did.  Additional information has been requested. 3/2/09 Per reporter/parent pt has not sought tx for fear of being prescribed psychiatric meds.  7/1/09 MR received for ER visit 5/8/09 with dx: Tachycardia, paroxysmal. Pt presented with c/o onset of palpitations, chest pressure/pain, mild SOB and H/A-frontal.   7/27/09 Medical records received, including cardiology consult, DOS 5/11/09 to 6/29/09. Assessment: Tachycardia. Patient complains of elevated heart rate and chest pain. Fever, body aches, did not feel right. Depression, mood swings, memory loss, muscle pain, back pain, aggessive behavior, isolating herself, abdominal cramps. Fatigue, anxiety. Depression. Sweats. Sometimes does not recognize people. Indigestion and heart burn. Knee and arthritis pain. Sleeping more.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, VARCEL
Symptoms: Myalgia, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no known medical history and allergies, who on 10-JUN-2008 was vaccinated with a first dose of GARDASIL.  On 10-JUN-2008 the patient experienced fever of 102 for three to four days.  She also started getting depressed, and she begun having mood swings, memory loss, achy back and muscle pain.  After she received the second dose of GARDASIL, she came down with a fever of 103 and the symptoms continued and had not improved.  There were no laboratory diagnostics performed.  The patient did not seek medical attention.  At the time of this report the patient had not recovered.  Follow up information received on 19-JAN-2009 stated that a phone call was received from the reporter, she mentioned that a physician did not administered the GARDASIL vaccine, a nurse did.  Additional information has been requested. 3/2/09 Per reporter/parent pt has not sought tx for fear of being prescribed psychiatric meds.  7/1/09 MR received for ER visit 5/8/09 with dx: Tachycardia, paroxysmal. Pt presented with c/o onset of palpitations, chest pressure/pain, mild SOB and H/A-frontal.   7/27/09 Medical records received, including cardiology consult, DOS 5/11/09 to 6/29/09. Assessment: Tachycardia. Patient complains of elevated heart rate and chest pain. Fever, body aches, did not feel right. Depression, mood swings, memory loss, muscle pain, back pain, aggessive behavior, isolating herself, abdominal cramps. Fatigue, anxiety. Depression. Sweats. Sometimes does not recognize people. Indigestion and heart burn. Knee and arthritis pain. Sleeping more.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, VARCEL
Symptoms: Depression, Mood swings
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter with no known medical history and allergies, who on 10-JUN-2008 was vaccinated with a first dose of GARDASIL.  On 10-JUN-2008 the patient experienced fever of 102 for three to four days.  She also started getting depressed, and she begun having mood swings, memory loss, achy back and muscle pain.  After she received the second dose of GARDASIL, she came down with a fever of 103 and the symptoms continued and had not improved.  There were no laboratory diagnostics performed.  The patient did not seek medical attention.  At the time of this report the patient had not recovered.  Follow up information received on 19-JAN-2009 stated that a phone call was received from the reporter, she mentioned that a physician did not administered the GARDASIL vaccine, a nurse did.  Additional information has been requested. 3/2/09 Per reporter/parent pt has not sought tx for fear of being prescribed psychiatric meds.  7/1/09 MR received for ER visit 5/8/09 with dx: Tachycardia, paroxysmal. Pt presented with c/o onset of palpitations, chest pressure/pain, mild SOB and H/A-frontal.   7/27/09 Medical records received, including cardiology consult, DOS 5/11/09 to 6/29/09. Assessment: Tachycardia. Patient complains of elevated heart rate and chest pain. Fever, body aches, did not feel right. Depression, mood swings, memory loss, muscle pain, back pain, aggessive behavior, isolating herself, abdominal cramps. Fatigue, anxiety. Depression. Sweats. Sometimes does not recognize people. Indigestion and heart burn. Knee and arthritis pain. Sleeping more.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This is in follow-up to report (s) previously submitted on 2/11/2009. Information has been received from a physician concerning a 12 year old female patient who on an unknown date was vaccinated with the first dose of GARDASIL 0.5 mL. After received the first dose of GARDASIL, the patient experienced pain in her whole arm. The patient was sent to the emergency room. On an unspecified date, the patient recovered from pain in her whole arm. Additional information has been requested. Follow up information has been received from the physician concerning the female patient with no illness at the time of vaccination, who on 25-NOV-2008 at the afternoon was vaccinated with the first dose of GARDASIL (Lot number 659657/1480U) IM 0.5 mL. Two-three days after approximately on 27-NOV-2008, the patient experienced severe pain on site of injection. The patient went to the emergency room. A X-ray of humerus was performed (results not provided). The patinet was treated with MOTRIN. No record was faxed to office of the emergency room visit. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a Registered Nurse concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who in July 2008, was vaccinated with first dose of GARDASIL (Lot # not provided) 0.5 ml, intramuscularly and at the end of August 2008 the patient received second dose of GARDASIL (Lot # not provided) 0.5ml, intramuscularly. There was no concomitant medication. After 2 days the patient received first dose of GARDASIL she experienced mild nausea. The nausea resolved within 2 days without treatment. The patient experienced moderately severe nausea starting 2 days after receiving her second dose. The nausea lasted 4-5 days and resolved without requiring treatment. The patient did not experience vomiting. There were no Laboratory Diagnostic performed. The patient sought medical attention by phone. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Fungal infection, Lymphadenopathy, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 21 year old daughter with no previous medical history reported who on 06-APR-2007 was vaccinated with the first dose of GARDASIL. On 07-JUN-2007, the patient was vaccinated with the second dose of GARDASIL and on 10-OCT-2007 with the third dose of GARDASIL. Concomitant therapy included birth control (unspecified). She had her papanicolaou test on 20-OCT-2007 and on 21-MAY-2008 and both came back ASCUS, and her last papanicolaou test on 03-DEC-2008 came back normal. In December 2007 and April 2008, the patient experienced yeast infections. In November 2008, the patient experienced swollen gland in her groin. Subsequently, the patient recovered. The patient sought unspecified medical attention. This is one of several reports provided by the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy, Drug exposure during pregnancy, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a licensed practical nurse for the Pregnancy Registry for GARDASIL, concerning a 26 year old female patient with a history of papilloma viral infection, who on 10-APR-2008 was vaccinated with the first dose of GARDASIL (Lot number 659964/1978U) 0.5 mL IM. On 11-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (660393/0067X) 0.5 mL IM and on 08-OCT-2008 was vaccinated with the third dose of GARDASIL (Lot number 660557/0072X) 0.5 mL IM. There was no concomitant medication. The nurse reported that the patient who received all three doses of GARDASIL was pregnant. A urine pregnancy test done on 08-OCT-2008 at the office was negative. The last menstrual period was on 14-OCT-2008 and the estimated delivery date will be on 21-JUL-2009. Follow up information was received from the LPN who reported that the patient with asthma (status post), had a 3 previous pregnancies (2 full term deliveries (39 weeks both) and 1 elective termination at 4 weeks). The patient did not had any birth defects or infant complications in any previous pregnancy. On 29-DEC-2008, the patient was placed on prenatal vitamins. On 13-0CT-2008 a PAP was performed, positive result for ASCUS and HRHPV. On 12-DEC-2008, a colposcopy was performed (results not provided). Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a licensed practical nurse for the Pregnancy Registry for GARDASIL, concerning a 26 year old female patient with a history of papilloma viral infection, who on 10-APR-2008 was vaccinated with the first dose of GARDASIL (Lot number 659964/1978U) 0.5 mL IM. On 11-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (660393/0067X) 0.5 mL IM and on 08-OCT-2008 was vaccinated with the third dose of GARDASIL (Lot number 660557/0072X) 0.5 mL IM. There was no concomitant medication. The nurse reported that the patient who received all three doses of GARDASIL was pregnant. A urine pregnancy test done on 08-OCT-2008 at the office was negative. The last menstrual period was on 14-OCT-2008 and the estimated delivery date will be on 21-JUL-2009. Follow up information was received from the LPN who reported that the patient with asthma (status post), had a 3 previous pregnancies (2 full term deliveries (39 weeks both) and 1 elective termination at 4 weeks). The patient did not had any birth defects or infant complications in any previous pregnancy. On 29-DEC-2008, the patient was placed on prenatal vitamins. On 13-0CT-2008 a PAP was performed, positive result for ASCUS and HRHPV. On 12-DEC-2008, a colposcopy was performed (results not provided). Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Infectious mononucleosis, Laboratory test abnormal, Mononucleosis heterophile test positive
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with no drug reactions or allergies who on 09-Dec-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. The mother reported that 7 to 10 days after vaccination, approximately on 16-Dec-2008, the patient experienced severe joint pains. Mother also stated the patient was brought to the emergency room but was not admitted in the hospital. Mother also reported that after some blood test done, the patient was diagnosed of "mononucleosis" Blood test was done 2 weeks after the patient received GARDASIL, approximately on 23-Dec-2008. The patient recovered at the end of December. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with no medical history and allergies and 0 previous pregnancies, who on 30-OCT-2008 was vaccinated with a 0.5 mL first dose of GARDASIL vaccine (lot #661530/0575X), intramuscularly. Concomitant therapy included ALESSE. On 30-OCT-2008 the patient discovered that she was pregnant, the nurse mentioned that the LMP was 18-NOV-2008, but the patient had an abnormal cycle and the LMP may had been a month earlier. Laboratory diagnostics studies performed include a urine pregnancy test on 18-DEC-2008 at the office, a pre-natal blood work drawn on 23-DEC-2008 (results pending) and a prenatal ultrasound scheduled for next week. Clonazepam (dates taken 20-OCT-2008 for 2 days), PREDNISONE (dates taken 22-NOV-2008 for 3 days) and chlorpromazine (dates taken 20-OCT-2008 for 2 days) were taken by the patient. No adverse effects reported. The patient sought medical attention through an office visit. follow up information received on 27-JAN-2009 from an initial pregnancy questionnaire stated that the patient had recurrent hiccups. Concomitant therapy included MENACTRA. CHLORPROMAZINE (25-NOV-2008 to 28-NOV-2008, 25 mg 3/day). PREDNISONE (22-NOV-2008 to 25-NOV-2008, 20 mg x 2 daily) and CLONAZEPAM (20-NOV-2008 to 22-NOV-2008, 0.25 mg 0.5 mg 2 x day) were taken by the patient for hiccup syndrome. On 07-JAN-2009 the patient had an ultrasound performed for dating, the fetal heart rate was 135; 1 weeks 0 days. The estimated delivery date was 26-AUG-2009 (previously reported 25-AUG-2009). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Depression, Drug exposure during pregnancy
Clinical narrative: Information has been received from a certified nurse midwife for the Pregnancy Registry for GARDASIL vaccine, concerning a 19 year old female who on 15-AUG-2008 was vaccinated intramuscularly with a first 0.5ml of GARDASIL vaccine. The patient sought medical attention at the practice. The patient's LMP was 05-AUG-2008. No adverse event. Follow-up information was received on 08-DEC-2008. It was reported that this was the patient's second Pregnancy, and she had one previous full term delivery. There is no birth defect and no infant complications in previous pregnancy. On 15-OCT-2008 the ultrasound showed intrauterine pregnancy 9 weeks and on 04-DEC-2008 MSAFP was performed. Medication taken during pregnancy included WELLBUTRIN, SR100 mg. BID, started on 06-NOV-2008 for depression. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cyst rupture, Drug exposure during pregnancy, Pelvic pain, Ultrasound scan abnormal
Clinical narrative: Information has been received from a Registered Nurse regarding the Pregnancy registry for HPV concerning a 24 year-old female with penicillin and dyes allergy and a history of abnormal pap smear, who on 01-MAY-2008 was vaccinated with the first dose of GARDASIL, on 01-JUL-2008 was vaccinated with the second dose of GARDASIL, and on 04-NOV-2008 was vaccinated with the third dose of GARDASIL (lot # 659962/1740U) 0.5 ml via intramuscular. There was no concomitant therapy. The patient saw the nurse. Urine pregnancy test was performed. The patient became pregnant after receiving GARDASIL and her last menstrual period was on 09-OCT-2008 and EDC is on 16-JUL-2009. Follow-up information has been received from a completed questionnaire on 14-JAN-2009 which reported: A female patient on 01-MAY-2008, 01-JUL-2008 and 04-NOV-2008 was vaccinated with three doses of GARDASIL (lot # 659962/1740U) respectively. The third dose of GARDASIL was also reported as WP-M902. The patient had one previous full term pregnancy, with no complications. It was confirmed that the patient's LMP was 09-OCT-2008 and the EDC was 16-JUL-2008. On 24-NOV-2008, the patient underwent an ultrasound due to pelvic pain. The result indicated Intrauterine Pregnancy at 6 weeks and 2 days and a ruptured corpus luteal cyst. Follow-up information has been received from the Registered Nurse on 16-Jan-2009 which reported: The patient remained pregnant and as of 05-DEC-2008, the ruptured corpus luteal cyst had completely resolved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia of pregnancy, Drug exposure during pregnancy, Laboratory test normal, Polyhydramnios, Pregnancy induced hypertension
Clinical narrative: Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL vaccine concerning a 24 year female with of asthma and drug allergic to penicillin, in AUG-2007 motor vehicle accident resulting in multiple fractures, left arm, left leg, right arm; liver and kidney damage; a splenectomy at the time of vaccination, discontinued all medications related to MVA prior to 12 weeks pregnant (PREVACID, NEXIUM), AMBIEN, SEROQUEL, CELEBREX, PROZAC), who on 22-OCT-2007 was vaccinated with the first dose of GARDASIL vaccine (lot# 655154/12100), 0.5ml intramuscular right deltoid, on 12-DEC-2007 was vaccinated the second dose of GARDASIL vaccine (lot#655327/1287U), 0.5ml intramuscular right deltoid. Concomitant therapy included VENTOLIN, fluticasone propionate (+) ADVAIR; prenatal vitamins (unspecified) daily. On 28-FEB-2008 the patient experienced the last menstrual period, and the estimated delivery date was on05-DEC-2008. On 01-APR-2008, the patient serum beta human chorionic gonadotropin test (B HCG; was positive. The patient was reported as a gravida 1, paro 0 (no pregnancies). On 07-APR-2008, the patient underwent an untrasound due to bleeding.  The results revealed a single live intrauterine pregnancy (SLIUP) at 5 weeks, 4 days. EDC 04-DEC-2008). On 27-MAY-2008, the patient's 1st trimester screen revealed normal nuchal translucency, at 12 weeks, 6 days. Additional follow-up information had been received from a completed pregnancy questionnaire on 05-JAN-2009: This report concerned a female patient with depression-anxiety and asthma. ETC was 04-DEC-2008. Concomitant therapy included PROZAC, ADAVIR, VENTOLIN, AMBIEN, and iron. During pregnancy, the patient experienced polyhydramnioe and PIH (pregnancy induced hypertension). The patient underwent multiple ultrasounds, non stress testing and PIH labs. PIH labs were normal. In April 1 2009 ADVAIR was discontinued. During delivery, the patient retained placenta-which required manual extraction and O+E. On 17-NOV-2008, 37 3/? weeks from LMP, a normal male infant was born with no congenital anomalies, 7 lbs 4 oz, apgar score 6.7. The patient  experienced postpartum anemia which required transfusion. PROZAC was switched to ZOLOFT postpartum. This is one of several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Retained placenta or membranes, Ultrasound scan abnormal
Clinical narrative: Information has been received from a Registered Nurse, for the Pregnancy Registry for GARDASIL vaccine concerning a 24 year female with of asthma and drug allergic to penicillin, in AUG-2007 motor vehicle accident resulting in multiple fractures, left arm, left leg, right arm; liver and kidney damage; a splenectomy at the time of vaccination, discontinued all medications related to MVA prior to 12 weeks pregnant (PREVACID, NEXIUM), AMBIEN, SEROQUEL, CELEBREX, PROZAC), who on 22-OCT-2007 was vaccinated with the first dose of GARDASIL vaccine (lot# 655154/12100), 0.5ml intramuscular right deltoid, on 12-DEC-2007 was vaccinated the second dose of GARDASIL vaccine (lot#655327/1287U), 0.5ml intramuscular right deltoid. Concomitant therapy included VENTOLIN, fluticasone propionate (+) ADVAIR; prenatal vitamins (unspecified) daily. On 28-FEB-2008 the patient experienced the last menstrual period, and the estimated delivery date was on05-DEC-2008. On 01-APR-2008, the patient serum beta human chorionic gonadotropin test (B HCG; was positive. The patient was reported as a gravida 1, paro 0 (no pregnancies). On 07-APR-2008, the patient underwent an untrasound due to bleeding.  The results revealed a single live intrauterine pregnancy (SLIUP) at 5 weeks, 4 days. EDC 04-DEC-2008). On 27-MAY-2008, the patient's 1st trimester screen revealed normal nuchal translucency, at 12 weeks, 6 days. Additional follow-up information had been received from a completed pregnancy questionnaire on 05-JAN-2009: This report concerned a female patient with depression-anxiety and asthma. ETC was 04-DEC-2008. Concomitant therapy included PROZAC, ADAVIR, VENTOLIN, AMBIEN, and iron. During pregnancy, the patient experienced polyhydramnioe and PIH (pregnancy induced hypertension). The patient underwent multiple ultrasounds, non stress testing and PIH labs. PIH labs were normal. In April 1 2009 ADVAIR was discontinued. During delivery, the patient retained placenta-which required manual extraction and O+E. On 17-NOV-2008, 37 3/? weeks from LMP, a normal male infant was born with no congenital anomalies, 7 lbs 4 oz, apgar score 6.7. The patient  experienced postpartum anemia which required transfusion. PROZAC was switched to ZOLOFT postpartum. This is one of several reports from the same source. Additional information has been requested.