chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with menstrual problems who in January 2008, was vaccinated with the first dose of GARDASIL (dose and route not reported). Concomitant therapy included albuterol and Zantac. In February 2008, after getting her first dose of GARDASIL, the patient developed vomiting, nausea and stomach cramps and pain lasting about 2 days after the completion of each menstrual period. The patient took blood tests and sonograms (results not reported). She didn't get her 2nd or 3rd doses. She sought medical attention. Her vomiting, nausea, stomach cramps and pain persisted. Additional information has been requested.  12/18/08 Reviewed PCP office records. FINAL DX: epigastric pain, RAD, possible gastritis Records reveal patient experienced cold s/s, felt hot, nauseated, difficulty breathing on 3/08 visit.  RTC 7/08 w/nipple discomfort.  RTC 9/08 LLQ pain & chest pain s/p vomiting & diarrhea.  Tx w/meds. Referred to ER & cardiology.  To return if no improvement.  No further visits available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hallucination, Headache
Clinical narrative: Information has been received from a physician concerning a 15 year old female who experienced headache and hallucination after the first dose of GARDASIL (lot # not provided). The patient reported the headache and hallucinations when she came in for the second vaccination. The patient did not seek medical attention. Subsequently, the patient recovered from headache and hallucination. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Keratitis, Laboratory test
Clinical narrative: Information has been received from a physician concerning her 20 year old daughter who wears eyeglasses and in the "end of August 2008" received her first dose of GARDASIL. The patient had no drug allergy. Soon after receiving the vaccination, the patient experienced a change in vision in one eye. The patient sought medical attention and it was diagnosed as keratitis by an ophthalmologist. The patient's keratitis persisted. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning 3 patients, 13 years old or more who were vaccinated with a dose of GARDASIL. Subsequently, the patients experienced syncope. No additional complications were reported. No outcomes were 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: Pelvic pain
Clinical narrative: Information has been received from a nurse concerning a female patient who experienced pelvic pain after receiving the first dose of GARDASIL. The outcome of the event was unknown. The reporter indicated that the patient's whole cheerleading squad also experienced the events after receiving the first dose of dose of GARDASIL. This is one of the several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain
Clinical narrative: Information has been received from a nurse concerning a female patient who experienced pelvic pain after receiving the first dose of GARDASIL.  The outcome of the event was unknown.  The reporter indicated that the patient's whole cheerleading squad also experienced the events after receiving the first dose of GARDASIL.  This is one of the several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain
Clinical narrative: Information has been received from a nurse who reported that her niece experienced pelvic pain after receiving the first dose of GARDASIL. The outcome of the event was unknown. The reporter indicated that the patient's whole cheerleading squad also experienced the events after receiving the first dose of dose of GARDASIL. This is one of the several reports recieved from the same source. Follow-up information was received from a physician who reported that they did not have this patient and they were unaware of any adverse reactions from their practice. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 16 year old granddaughter who 1 and 1/2 years ago, was vaccinated with a series of GARDASIL.  Last month, the patient's Pap test was abnormal.  It was not reported whether the patient sought medical attention.  No further information is available.
Age: 21.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received form the mother concerning her 21 year old daughter with a history of drug reaction to VERSED who in October 2006 was vaccinated with a first dose of GARDASIL and on unspecified dates was vaccinated with second and third doses of GARDASIL. Concomitant therapy included FLUSHIELD. It is reported that the patient received all three dose of GARDASIL and then two times in March 2008 she had a PAP Test done and they both came back abnormal. In March 2008, the patient was diagnosed with a mild case of dysplasia (HPV). At the time of reporting, the patient's mild case of dysplasia (HPV) persisted. The patient had sought medical attention of the physician. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female with no history and no known drug allergies, who on 01-JUL-2008 was vaccinated with the first dose of GARDASIL  intramusclar. There was no concomitant medication. On 13-OCT-2008 the patient was vaccinated with the second dose of GARDASIL. On 13-Oct-2008, after administration of the patient's second dose, the patient experienced severe fatigue and a headache. The patient did not recover from fatigue and headache. The patient sought medical attention via telephone. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a nurse concerning a female, who on 13-OCT-2008, was vaccinated with a first 0.5 ml dose of GARDASIL (lot # was not reported). On 13-OCT-2008, the patient experienced headache after the vaccination. The patient sought medical attention. At the time of reporting, it was unknown if the patient recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ear pain, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning a 24 year old female with seasonal allergy who on 09-OCT-2008 was vaccinated IM with the first 0.5ML dose of GARDASIL (lot # 661044/0548X).  Concomitant therapy included montelukast sodium (MSD).  On 09-OCT-2008, about 6 hours after vaccination the patient experienced tingling of outside of ears and ears became painful to touch which became worse when talking.  No treatment required.  The patient sought medical attention by phone.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine.  Subsequently the patient passed out at the office.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Decreased appetite, Dysgeusia, Fatigue, Feeling abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female who on 06-OCT-2008 was vaccinated with GARDASIL (lot # 660612/0229X).  Concomitant therapy included YAZ.  It was reported that the patient experienced numerous adverse reactions following vaccination with GARDASIL.  The patient experienced pain at injection site immediately following vaccination, but it was described as "not that bad".  The next day (07-OCT-2008) the patient felt very tired and by Wednesday (08-OCT-2008) the patient felt tired, had a fever of 100.1, experienced nausea with a "fill feeling", taste disturbance.  The rest of the week the tiredness and fever continued with no mention of nausea.  The patient would get a fever around 3 or 4 in the afternoon.  ALEVE was taken for the fever.  On Sunday (12-OCT-2008) the patient felt better, but Monday (13-OCT-2008) the patient called complaining again of tiredness and fever, but no nausea.  The tiredness on Monday (13-OCT-2008) was described as not as bad.  The patient sought medical attention.  At the time of this report, the patient was recovering.  Follow-up information has been received from a health professional concerning a 22 year old female with no known drug allergies who on 06-OCT-2008, at 14:00, was vaccinated IM with the first dose of GARDASIL (lot # 660612/0229X) in the left arm.  On 08-OCT-2008, at 8:00, the patient started feeling bad, feeling tired, fever of 100.1, nausea, not able to taste food, pain at injection site, and was not able to eat.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Nausea, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female who on 06-OCT-2008 was vaccinated with GARDASIL (lot # 660612/0229X).  Concomitant therapy included YAZ.  It was reported that the patient experienced numerous adverse reactions following vaccination with GARDASIL.  The patient experienced pain at injection site immediately following vaccination, but it was described as "not that bad".  The next day (07-OCT-2008) the patient felt very tired and by Wednesday (08-OCT-2008) the patient felt tired, had a fever of 100.1, experienced nausea with a "fill feeling", taste disturbance.  The rest of the week the tiredness and fever continued with no mention of nausea.  The patient would get a fever around 3 or 4 in the afternoon.  ALEVE was taken for the fever.  On Sunday (12-OCT-2008) the patient felt better, but Monday (13-OCT-2008) the patient called complaining again of tiredness and fever, but no nausea.  The tiredness on Monday (13-OCT-2008) was described as not as bad.  The patient sought medical attention.  At the time of this report, the patient was recovering.  Follow-up information has been received from a health professional concerning a 22 year old female with no known drug allergies who on 06-OCT-2008, at 14:00, was vaccinated IM with the first dose of GARDASIL (lot # 660612/0229X) in the left arm.  On 08-OCT-2008, at 8:00, the patient started feeling bad, feeling tired, fever of 100.1, nausea, not able to taste food, pain at injection site, and was not able to eat.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Grip strength decreased, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a physician's assistant concerning a 17 year old female with hypersensitivity and anxiety, who on 11-JAN-2008, was vaccinated with the first dose of GARDASIL, and vaccinated IM with the third 0.5 ml dose of GARDASIL (lot # 0947X) on 25-SEP-2008. Concomitant therapy included sertraline HCL (ZOLOFT), hormonal contraceptive (unspecified) and albuterol. On 05-OCT-2008, the patient experienced muscle soreness, numbness and tingling of left arm. The left arm was painful with movement. An exam in the office on 13-OCT-2008 revealed decreased strength of the left hand grip. The patient was prescribed a tapering course of prednisone and rest. The patient was not recovered by the time of this report. The patient visited office for medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Biliary dyskinesia, Cholecystectomy, Headache
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female with chronic sinusitis who on 27-JUL-2007 received the first dose of GARDASIL vaccine (yeast) (lot # 658222/0927U), 0.5ml.  On 08-Nov-2007, the patient received the second dose of GARDASIL vaccine (yeast) (lot # 659437/12660), and on 17-Mar-2008 received the third dose of GARDASIL (yeast) (lot # 659182/1757U).  Concomitant therapy included injected birth control.  After the second dose the patient began to have headaches and abdominal pain.  The patient had her gall bladder removed at that time because of biliary diskinesia.  The patient's headaches and abdominal pain persisted.  The patient sought medical attention.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL, Lot # 660389/1968U.  It was reported that a "couple of weeks later", the patient developed a lump at the injection site.  The patient was seen by a surgeon and the lump was removed.  The surgeon stated that the lump was due to GARDASIL vaccine.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning her daughter who on 30-JUN-2008 was vaccinated with the first dose of GARDASIL.  The nurse reported that the patient had a fever after receiving the first dose.  The patient started to have fever just days prior to receiving her second dose of GARDASIL administered on 01-OCT-2008.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Headache, Nausea
Clinical narrative: Information has been received from a nurse for the pregnancy registry for HPV concerning a 22 female with gastroesophageal reflux and a history of headache, who on 11-AUG-2008, was vaccinated with the first dose of GARDASIL (660620/0571X), I.M. Concomitant therapy included ranitidine. On 11-Aug-2008 and 09-Sep-2008, the beta-human chorionic gonadotropin tests were negative. On 14-OCT-2008, the patient came to the office complaining of headache and nausea since receiving her first dose of GARDASIL. A pregnancy test during her visit revealed that she is pregnant. The patient's LMP was 13-SEP-2008 and EDD 20-JUN-2009.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from two registered nurses for the pregnancy registry for GARDASIL and the initial pregnancy questionnaire, concerning a 22 year old female with penicillin allergy who on 21-JUL-2008 was vaccinated with the first dose of GARDASIL, Lot # 660553/0070X.  On 18-SEP-2008, the patient was vaccinated with the second dose of GARDASIL, Lot # 660616/0570X.  Concomitant therapy included EFEXOR, prenatal vitamins and MACROBID.  The patient was pregnant.  The patient's LMP was on 20-AUG-2008 and EED on 27-MAY-2009.  In follow-up information was reported that the estimated conception date was 26-AUG-2008.  Unspecified routine OB labs were normal.  On 13-OCT-2008 ultrasound was performed because the patient was bleeding and it showed results within normal limits.  It was reported that the patient had no previous pregnancies.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Back pain, Blood test, Diarrhoea, Dyspnoea
Clinical narrative: Initial and follow-up information has been received from a mother concerning her 18 year old daughter with no medical history reported, wasp stings allergy and pecans allergy who "about 6 months ago" in approximately April 2008, was vaccinated with a dose of GARDASIL,  0.5 ml. Concomitant therapy included ethinyl estradiol/norgesstimate (ORTHO TRI-CYCLEN). After receiving each of her three GARDASIL shots, the patient experienced pain and redness at the injection site. Also, after the third shot the patient experienced pain throughout her entire body, swelling and numbness that started on her left sided and has also moved to her right side. The patient has difficulty walking. The physician prescribed diphenhydramine hydrochloride (BENADRYL) and ibuprofen (ADVIL). On an unspecified date, a blood work was performed (results not provided). In follow-up information the mother reported that her daughter was experiencing difficulty breathing, pains in her lower back, constant diarrhea, swollen stomach and recently she started to have numbness and tingling on her hands and bottom of the feet and toes. On 16-OCT-2008, patient was given mixed steroids shot for any allergic reaction due to GARDASIL and then she experienced elevated blood pressure. On 18-OCT-2008, patient experienced pain from her heart down to her hand and she was shaky and weak as well. Later, physician did an eletrocardiogram (EKG), but the results were normal. He gave her pain shot. On 20-OCT-2008, she was prescribed ibuprofen (manufacturer unknown) 600 mg, but that did not help her. On 23-OCT-2008, she was given an "ultra monitor" for heart (result not reported) and will be doing another echocardiogram soon. Caller also mentioned that patient will be seeing a rheumatologist on 04-NOV-2008 and neurologist on 31-OCT-2008. On 27-OCT-2008, the patient developed an itchy rash between her left fingers and was using antibiotic ointment to treat it. At the timer of the report, physician prescribed her cyclobenzaprine hydrochloride (FLEXERIL) for muscle relaxation, but it makes her very tired. Finally, physician stated that if she does not improve from all these medications physician will hospitalize her. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Gait disturbance, Hypersensitivity, Hypoaesthesia, Injection site erythema
Clinical narrative: Initial and follow-up information has been received from a mother concerning her 18 year old daughter with no medical history reported, wasp stings allergy and pecans allergy who "about 6 months ago" in approximately April 2008, was vaccinated with a dose of GARDASIL,  0.5 ml. Concomitant therapy included ethinyl estradiol/norgesstimate (ORTHO TRI-CYCLEN). After receiving each of her three GARDASIL shots, the patient experienced pain and redness at the injection site. Also, after the third shot the patient experienced pain throughout her entire body, swelling and numbness that started on her left sided and has also moved to her right side. The patient has difficulty walking. The physician prescribed diphenhydramine hydrochloride (BENADRYL) and ibuprofen (ADVIL). On an unspecified date, a blood work was performed (results not provided). In follow-up information the mother reported that her daughter was experiencing difficulty breathing, pains in her lower back, constant diarrhea, swollen stomach and recently she started to have numbness and tingling on her hands and bottom of the feet and toes. On 16-OCT-2008, patient was given mixed steroids shot for any allergic reaction due to GARDASIL and then she experienced elevated blood pressure. On 18-OCT-2008, patient experienced pain from her heart down to her hand and she was shaky and weak as well. Later, physician did an eletrocardiogram (EKG), but the results were normal. He gave her pain shot. On 20-OCT-2008, she was prescribed ibuprofen (manufacturer unknown) 600 mg, but that did not help her. On 23-OCT-2008, she was given an "ultra monitor" for heart (result not reported) and will be doing another echocardiogram soon. Caller also mentioned that patient will be seeing a rheumatologist on 04-NOV-2008 and neurologist on 31-OCT-2008. On 27-OCT-2008, the patient developed an itchy rash between her left fingers and was using antibiotic ointment to treat it. At the timer of the report, physician prescribed her cyclobenzaprine hydrochloride (FLEXERIL) for muscle relaxation, but it makes her very tired. Finally, physician stated that if she does not improve from all these medications physician will hospitalize her. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain, Paraesthesia, Rash pruritic, Swelling
Clinical narrative: Initial and follow-up information has been received from a mother concerning her 18 year old daughter with no medical history reported, wasp stings allergy and pecans allergy who "about 6 months ago" in approximately April 2008, was vaccinated with a dose of GARDASIL,  0.5 ml. Concomitant therapy included ethinyl estradiol/norgesstimate (ORTHO TRI-CYCLEN). After receiving each of her three GARDASIL shots, the patient experienced pain and redness at the injection site. Also, after the third shot the patient experienced pain throughout her entire body, swelling and numbness that started on her left sided and has also moved to her right side. The patient has difficulty walking. The physician prescribed diphenhydramine hydrochloride (BENADRYL) and ibuprofen (ADVIL). On an unspecified date, a blood work was performed (results not provided). In follow-up information the mother reported that her daughter was experiencing difficulty breathing, pains in her lower back, constant diarrhea, swollen stomach and recently she started to have numbness and tingling on her hands and bottom of the feet and toes. On 16-OCT-2008, patient was given mixed steroids shot for any allergic reaction due to GARDASIL and then she experienced elevated blood pressure. On 18-OCT-2008, patient experienced pain from her heart down to her hand and she was shaky and weak as well. Later, physician did an eletrocardiogram (EKG), but the results were normal. He gave her pain shot. On 20-OCT-2008, she was prescribed ibuprofen (manufacturer unknown) 600 mg, but that did not help her. On 23-OCT-2008, she was given an "ultra monitor" for heart (result not reported) and will be doing another echocardiogram soon. Caller also mentioned that patient will be seeing a rheumatologist on 04-NOV-2008 and neurologist on 31-OCT-2008. On 27-OCT-2008, the patient developed an itchy rash between her left fingers and was using antibiotic ointment to treat it. At the timer of the report, physician prescribed her cyclobenzaprine hydrochloride (FLEXERIL) for muscle relaxation, but it makes her very tired. Finally, physician stated that if she does not improve from all these medications physician will hospitalize her. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor, Vaccine positive rechallenge
Clinical narrative: Initial and follow-up information has been received from a mother concerning her 18 year old daughter with no medical history reported, wasp stings allergy and pecans allergy who "about 6 months ago" in approximately April 2008, was vaccinated with a dose of GARDASIL,  0.5 ml. Concomitant therapy included ethinyl estradiol/norgesstimate (ORTHO TRI-CYCLEN). After receiving each of her three GARDASIL shots, the patient experienced pain and redness at the injection site. Also, after the third shot the patient experienced pain throughout her entire body, swelling and numbness that started on her left sided and has also moved to her right side. The patient has difficulty walking. The physician prescribed diphenhydramine hydrochloride (BENADRYL) and ibuprofen (ADVIL). On an unspecified date, a blood work was performed (results not provided). In follow-up information the mother reported that her daughter was experiencing difficulty breathing, pains in her lower back, constant diarrhea, swollen stomach and recently she started to have numbness and tingling on her hands and bottom of the feet and toes. On 16-OCT-2008, patient was given mixed steroids shot for any allergic reaction due to GARDASIL and then she experienced elevated blood pressure. On 18-OCT-2008, patient experienced pain from her heart down to her hand and she was shaky and weak as well. Later, physician did an eletrocardiogram (EKG), but the results were normal. He gave her pain shot. On 20-OCT-2008, she was prescribed ibuprofen (manufacturer unknown) 600 mg, but that did not help her. On 23-OCT-2008, she was given an "ultra monitor" for heart (result not reported) and will be doing another echocardiogram soon. Caller also mentioned that patient will be seeing a rheumatologist on 04-NOV-2008 and neurologist on 31-OCT-2008. On 27-OCT-2008, the patient developed an itchy rash between her left fingers and was using antibiotic ointment to treat it. At the timer of the report, physician prescribed her cyclobenzaprine hydrochloride (FLEXERIL) for muscle relaxation, but it makes her very tired. Finally, physician stated that if she does not improve from all these medications physician will hospitalize her. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician who heard from the local news, that a female who was vaccinated with a dose of GARDASIL vaccine (yeast) experienced nausea and vomiting and was hospitalized (length of time unspecified).  The patient's outcome was not reported.  In follow-up, the office nurse reported she was not familiar with any adverse events being reported from their office.  Attempts are being made to verify the existence of an identifiable patient and reporter.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chills, Nausea
Clinical narrative: Information has been received from a nurse concerning a 21 year old female with ovarian cyst and no drug allergies reported who on 09-SEP-2008 was vaccinated with the first and only dose of GARDASIL IM and experienced nausea, chills and stomach pain right after receiving vaccination.  There was no concomitant medication.  The symptoms disappeared one hour after the vaccination.  The patient did not seek medical attention.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage, Inappropriate schedule of drug administration, Smear cervix abnormal, Ultrasound scan
Clinical narrative: Information has been received from a certified nurse midwife assistant for the pregnancy registry for GARDASIL, concerning a 27 year old female with a history of papanicolaou smear abnormal (1998), caesarean section (1999), normal deliveries (2002 and 2006) and no known allergies who on 02-MAY-2007 was vaccinated with the first dose of GARDASIL (Lot # 657005/0314U) into the left deltoid.  Concomitant therapy included NORDETTE and prenatal vitamins daily.  The patient had her last menstrual period on 10-JUL-2008.  In August 2008, the patient experienced light bleeding.  On 10-SEP-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660393/0067X) into the right deltoid and was pregnant.  On an unspecified date, a routine blood work was performed (results not provided).  The patient sought an initial pregnancy exam as medical attention.  The patient had 3 previous pregnancies and 3 full term deliveries (40, 39 and 40 weeks).  No birth defects in previous pregnancies and no infant complications were reported.  On 10-OCT-2008, an ultrasound was performed but was too early for evaluation dating.  A second ultrasound was scheduled for 27-OCT-2008.  The estimated date of delivery was 16-APR-2009.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syphilis test positive
Clinical narrative: Information has been received form a physician concerning a female who has tested positive for syphilis test several days after receiving the second dose of GARDASIL (therapy date, route, site unspecified). At the time of this report the patient was not recovered. The patient sought medical attention, she saw a physician. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Electrocardiogram, Hot flush, Laboratory test, Nausea
Clinical narrative: Information has been received from a nurse practioner concerning a 25 year old female with a history of anemia (blood transfusion November, 2007) and drug reactions or allergies to penicillin and EFFEXOR (not specified) who on 09-APR-2008 was vaccinated with the first dose of GARDASIL intramuscularly in the arm. On 10-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (lot#659655/1486U). On 10-OCT-2008, the patient was vaccinated with the third dose of GARDASIL (lot#661044/0548X). On 10-OCT-2008, the patient developed palpitations, tachycardia, nausea, and hot flashes within 30 minutes after the third dose of GARDASIL. On 10-OCT-2008 the patient was taken to the emergency room via ambulance and administered BENADRYL. The patient again experienced hot flashes, nausea, and tachycardia and went to the emergency room in the hospital where the patient works (date of treatment at the second emergency room is unknown). The patient underwent an electrocardiogram, chest X-ray, and unspecified lab work. The patient continues with symptoms of hot flashes, nausea and tachycardia that "comes and goes." The patient is out of work and has a follow up appointment with an unspecified primary care provider. The patient reported a similar reaction to EFFEXOR in the past (specified symptoms unspecified). No other symptoms or treatment reported. No other information available. Follow up AE information: The nurse practitioner called back to report that the patient has been diagnosed with thyroiditis. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Tachycardia, Thyroiditis
Clinical narrative: Information has been received from a nurse practioner concerning a 25 year old female with a history of anemia (blood transfusion November, 2007) and drug reactions or allergies to penicillin and EFFEXOR (not specified) who on 09-APR-2008 was vaccinated with the first dose of GARDASIL intramuscularly in the arm. On 10-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (lot#659655/1486U). On 10-OCT-2008, the patient was vaccinated with the third dose of GARDASIL (lot#661044/0548X). On 10-OCT-2008, the patient developed palpitations, tachycardia, nausea, and hot flashes within 30 minutes after the third dose of GARDASIL. On 10-OCT-2008 the patient was taken to the emergency room via ambulance and administered BENADRYL. The patient again experienced hot flashes, nausea, and tachycardia and went to the emergency room in the hospital where the patient works (date of treatment at the second emergency room is unknown). The patient underwent an electrocardiogram, chest X-ray, and unspecified lab work. The patient continues with symptoms of hot flashes, nausea and tachycardia that "comes and goes." The patient is out of work and has a follow up appointment with an unspecified primary care provider. The patient reported a similar reaction to EFFEXOR in the past (specified symptoms unspecified). No other symptoms or treatment reported. No other information available. Follow up AE information: The nurse practitioner called back to report that the patient has been diagnosed with thyroiditis. No further information was provided. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Inappropriate schedule of drug administration, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no allergies and a family history of endometriosis but she tested negative at the beginning of this year, who on 15-DEC-2006 was vaccinated with the first dose of GARDASIL (lot # 655165/1425F) 0.5ml injection.  On 20-FEB-2007, the patient was vaccinated with the second dose of GARDASIL (lot # 655165/1425F).  On 11-MAR-2008 the patient experienced abdominal pain.  On 30-OCT-2008, the patient was vaccinated with the third dose of GARDASIL (lot # 659435/1265U).  Concomitant therapy included ORTHO-NOVUM.  On 13-OCT-2008 the patient experienced enflamed lymph nodes in the groin.  The patient's present status was not recovered.  The patient sought unspecified medical attention.  No lab diagnostics studies performed.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Periorbital oedema
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in August 2008, was vaccinated with the first dose of GARDASIL.  On 13-OCT-2008 was vaccinated with the second dose of GARDASIL.  The patient got a swollen eye (eye unspecified) after receiving GARDASIL.  On 15-OCT-2008 the patient was seen in the office today for a swollen eye diagnosed as periorbital edema.  In August 2008 the patient had a similar reaction following the first dose of GARDASIL, but the reaction after the first dose was described as "worse".  The physician treated the patient with eye drops (unspecified) and BENADRYL.  No time frame development information was available other than the mother brought the patient in "right away".  The patient's present status was not recovered.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nodule, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a mother concerning her 19 year old daughter with no known pertinent medical history or known drug reaction/allergies, who on 04-SEP-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included birth control pills. The mother reported that on 02-OCT-2008, the patient experienced strange lumps on her one leg after getting GARDASIL. On an unknown date an MRI was preformed. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope, Syncope vasovagal
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 16 year old female patient who on 25-AUG-2008, also reported as about a month ago, was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot number and site not reported). On 25-AUG-2008, the patient fainted and experienced dizzy and vaso vagal at the office after getting GARDASIL. The patient stayed at the office for a little while for monitoring and was released soon after. No lab diagnostic studies were performed. The patient recovered on the same date as injection date. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with the first dose of GARDASIL IM, 0.5 ml.  One month after, the patient experienced Bell's Palsy.  On an unknown date, the patient completed the three dose series and the symptom disappeared.  The patient sought medical attention with the physician.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Information has been received from a consumer concerning hr school age daughter with a history of getting a fever about once a month, who on 15-OCT-2008, was vaccinated with GARDASIL (lot # not provided). Concomitant therapy included influenza virus vaccine (unspecified). On 15-OCT-2008, within one hour after the vaccination, the patient experienced fever and sore throat. The fever is continuing at the time of the report on 16-OCT-2008, and was recorded as 102 degrees F. The patient's sore throat persisted. The patient did not seek medical attention. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a 13 year old female who "about 2 to 3 weeks ago" on approximately 25-SEP-2008, received the first dose of GARDASIL vaccine (lot# not provided). Subsequently the patient experienced joint pain in one of her knees. The patient sought medical attention and he Orthopedic doctor said it could be from the vaccine. The patient's joint pain in one of knees persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 20 year old female who was vaccinated with three doses of GARDASIL.  There was no concomitant medication.  Only after the third dose, the patient broke out in hives on her face, arms and legs.  Subsequently, patient recovered.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury
Clinical narrative: Information has been received from a nurse practitioner concerning a 19-20 year old female who was vaccinated with the first dose of GARDASIL, and then after receiving the vaccine, the patient had fell off the exam table and hit her head on the counter. The nurse practitioner reported that the patient recovered, and then two months later had received the second dose of the vaccine. Unspecified medical attention was sought. No further AE information provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician who was told that a female patient of another physician in the same practice, was vaccinated on 16-OCT-2008 with a dose of GARDASIL 0.5 mL IM.  Subsequently, the patient fainted while in the office.  The patient was unconscious for 20 minutes and was transported by ambulance to the Emergency Room.  It was not known yet if the patient was admitted to the hospital or what treatment was given.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a immunization coordinator concerning 2 or 3 patients who were vaccinated with GARDASIL. Subsequently the patients passed out after getting vaccinated with GARDASIL. All of the patients had recovered on unspecified date. The patients had sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received form a nurse practitioner concerning a 16 year old female patient who in 2007 was vaccinated with the three doses of GARDASIL (Lot numbers not available). the last month(September 2008), the patient developed abnormal pap smear after receiving all 3 doses of GARDASIL vaccine. the patient sought unspecified medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a adolescent female who was vaccinated intramuscularly with a 0.5ml dose of GARDASIL (lot # not reported). The patient fainted after receiving the vaccine. After she recovered. She stayed at the office for 15 minutes, as she was checking out she fainted again. Outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Nasal congestion, Oropharyngeal pain, Pyrexia, Throat irritation
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female patient with a bee sting allergy, who on 14-OCT-2008, was vaccinated with the first dose of GARDASIL (lot # 660555/0278X), 0.5 ml, IM. There was no concomitant medication. On 14-OCT-2008, the patient developed a fever of 101 F, stuffy nose, wheezing, itching sore throat, and swollen upper middle lip about 18 hours after receiving the first dose of GARDASIL. The patient took an unspecified amount of diphenhydramine hydrochloride (BENADRYL), and most of the symptoms resolved by the patient phoned the nurse practitioner on 16-Oct-2008. The patient's only remaining symptom was a stuffy nose. The patient sought medical attention by phone. Additional information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Wheezing
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female patient with a bee sting allergy, who on 14-OCT-2008, was vaccinated with the first dose of GARDASIL (lot # 660555/0278X), 0.5 ml, IM. There was no concomitant medication. On 14-OCT-2008, the patient developed a fever of 101 F, stuffy nose, wheezing, itching sore throat, and swollen upper middle lip about 18 hours after receiving the first dose of GARDASIL. The patient took an unspecified amount of diphenhydramine hydrochloride (BENADRYL), and most of the symptoms resolved by the patient phoned the nurse practitioner on 16-Oct-2008. The patient's only remaining symptom was a stuffy nose. The patient sought medical attention by phone. Additional information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Joint stiffness, Myalgia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 20 year old female with no known drug allergies and no pertinent medical history reported who on 15-NOV-2007 was vaccinated with the first dose of GARDASIL. On 25-JAN-2008, the patient was vaccinated with a second dose of GARDASIL. There was no concomitant medication. After each dose of GARDASIL, the patient developed muscle aches, stiff joints with creaking and a strange feeling. The patient did not seek medical attention. The symptoms developed within hours of vaccinations and resolved within a day or 2. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a female who on an unknown date was vaccinated with an unspecified dose of GARDASIL, 0.5 mL.  Lot # was not provided.  Subsequently, the patient developed severe pain and possible cellulitis at the injection site after the GARDASIL injection.  The patient sought unspecified medical attention.  At the time of reporting the patient had recovered on an unspecified date.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site pain, Muscle strain, Nuclear magnetic resonance imaging normal, Pain, Pain in extremity
Clinical narrative: This is in follow-up to report (s) previously submitted on 11/14/2008. Information has been received from a health professional concerning and approximately 16 year old female with penicillin allergy who on 12-NOV-2007 was vaccinated with the first dose of GARDASIL vaccine, intramuscularly. On unspecified dates, the patient was vaccinated with the second and third doses of GARDASIL vaccine. Secondary suspect therapy included VARIVAX. Other concomitant therapy included PPD TINE TEST). About two months after completing the GARDASIL Vaccine vaccination series, in approximately 2008, the patient developed arm pain near the injection site and on the opposite of the arm, in the triceps area. The pain is not constant but it does seem to get worse with use. The patient did not see medical attention. At the time of reporting the patient had not recovered. On an unspecified date, was performed to the patient an X-ray and an ultrasound, results for both were normal. Follow up information was received on 05-JAN-2009 from the nurse practitioner. It was reported that the female patient received the third dose of GARDASIL on 07-JUL-2008 (659968/0847X) intramuscularly in the left arm. ON 07-AUG-2008 the patient complained about arm pain. It was reported that the patient had a strain to weight lifting. The ultrasound and the Magnetic Resonance Imaging were negative. The patient recovered on 30-OCT-2008. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Ultrasound scan normal, X-ray normal
Clinical narrative: This is in follow-up to report (s) previously submitted on 11/14/2008. Information has been received from a health professional concerning and approximately 16 year old female with penicillin allergy who on 12-NOV-2007 was vaccinated with the first dose of GARDASIL vaccine, intramuscularly. On unspecified dates, the patient was vaccinated with the second and third doses of GARDASIL vaccine. Secondary suspect therapy included VARIVAX. Other concomitant therapy included PPD TINE TEST). About two months after completing the GARDASIL Vaccine vaccination series, in approximately 2008, the patient developed arm pain near the injection site and on the opposite of the arm, in the triceps area. The pain is not constant but it does seem to get worse with use. The patient did not see medical attention. At the time of reporting the patient had not recovered. On an unspecified date, was performed to the patient an X-ray and an ultrasound, results for both were normal. Follow up information was received on 05-JAN-2009 from the nurse practitioner. It was reported that the female patient received the third dose of GARDASIL on 07-JUL-2008 (659968/0847X) intramuscularly in the left arm. ON 07-AUG-2008 the patient complained about arm pain. It was reported that the patient had a strain to weight lifting. The ultrasound and the Magnetic Resonance Imaging were negative. The patient recovered on 30-OCT-2008. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with her third dose of GARDASIL (therapy started date, route, site unknown).  Subsequently the patient had been having pain all over her arm.  The patient didn't seek medical attention.  The patient's outcome was unknown.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Nausea, Pregnancy test negative
Clinical narrative: Information has been from a physician concerning a 17 year old female who was vaccinated with a first  dose of GARDASIL (lot #, route not reported) about "1 week ago", on approximately 09-OCT-2008. Yesterday, on 15-OCT-2008, the patient had office visit and complained of feeling dehydrated and nauseous. It was reported that the patient was sexually active, but on unspecified birth control. Urine pregnancy test was negative. At the time of reporting, 16-OCT-2008, the patient not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a female who was vaccinated with the first dose of GARDASIL in the "past 1 week". Subsequently, the patient developed a rash over most of her body in the "past 1 week". At the time of the report the was not recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain, Injection site pain
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 15 year old female who on 22-Sep-2008 was vaccinated intramuscularly in the left arm with the first dose of GARDASIL. Subsequently the patient developed a pea sized "knot" or lump under the skin at the injection site. The time frame development of the lump was not specified at the time of the report. The lump was tender or sore to the touch. The patient was seen by a nurse and used warm compresses on the lump. At the time of reporting (17-Oct-2008) the patient was not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2008. Follow up information was received from a registered nurse reporting that the 15 year old female patient with no reported relevant history was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (lot #) on 22-Sep-2008 at 10:00. There was no illness at the time of vaccination. On 17-Oct-2008 at 9:45 the patient had a bump on her right arm where she received her first GARDASIL. The bump was tender to touch. The patient tried warm compress without success. The patient was a student. No treatment provided. No relevant diagnostic test or laboratory test were performed. The outcome was unknown. Additional information has been requested.