chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a certified medical assistant for the Pregnancy Registry for GARDASIL concerning a female who on 26-MAR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). There was no concomitant medication. On 28-MAY-2008 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# not reported) and was pregnant. The patient's LMP was approximately 15-APR-2008. Subsequently the patient experienced no known symptoms. The patient has a positive pregnancy test on 10-JUN-2008. The patient's outcome was not reported. Follow-up information has been received from a physician for the Pregnancy Registry for GARDASIL concerning the 25 year old female with asthma and anxiety, a history of 1 pregnancy and 1 normal delivery and a history of vaginal disorder and some complication on 26-MAR-2008 was vaccinated IM with the first dose GARDASIL, on 28-MAY-2008 was vaccinated with the second dose and on 11-MAR-2009 was vaccinated with the third dose (lot #: 660553/0070X). The patient became pregnant in April 2008, the date of last menstrual period was 18-APR-2008, estimated delivery date was 25-JAN-2009. On 22-JAN-2009 the patient delivered a normal, female infant with no congenital anomalies. The baby's weight was 7 LB 14.5 ounce, length was 21.75 inch, head circumference was 14.25 inch. Apgar test score was 8/9. On an unspecified date, group B strep test of the infant was positive. Initial complete blood count secondary to group B strep positive was 9 band. C-reactive protein test was negative and blood culture was negative. At the time of this report, bandemia resolved. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Urine analysis abnormal
Clinical narrative: Information has been received from a medical assistant for the pregnancy registry for GARDASIL concerning an 18 year old female with no known allergies or pertinent medical history who on 31-OCT-2007 was vaccinated IM with the first dose of GARDASIL 0.5 ml. There was no concomitant medication. The medical assistant reported that on 31-OCT-2007 the patient received her first dose of GARDASIL and was subsequently determined to be pregnant. On 18-JAN-2008 Urine pregnancy test was performed (result:positive). Last menstrual period was reported as October 2007. The patient sought medical attention, "office visit". There was no product quality complaint. The patient has not received her second or third dose of GARDASIL. Follow-up information has been received from a physician concerning the patient. It was reported that the patient had a spontaneous vaginal delivery of a healthy normal-appearing male on 16-JUL-2008, at term. The baby's APGARS were 8 and 9. The mother had a normal prenatal course, with normal fetal anatomy survey at 20 weeks estimated gestational age, though the spine was not fully visualized due to the fetal positioning. The mother was treated with antibiotics in labor as she was found to be group beta strep positive in her urine prenatally. The mother was seen again for a postpartum visit in August 2008: she was doing well and reported that the baby was also doing well. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Congenital anomaly, Drug exposure during pregnancy, Induced labour, Rash
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning her daughter a 14 year old female with scoliosis and no previous pregnancies who in 2007 was vaccinated with the first dose of GARDASIL 0.5ml IM when she was 17 weeks pregnant. On 25-JUL-2007 the patient was vaccinated with the second dose of GARDASIL (lot # 656050/0245U). Concomitant vaccine on 25-JUL-2007 included DTAP (unspecified) and meningococcal vaccine (unspecified). The male baby was born healthy on 04-JAN-2008. There were no congenital anomalies or other complications. The baby weighed 7 pounds, 3.8 ounces and was 21 inches long. APGAR scores were 9/9 the patient sought medical attention. Additional information is not expected. In follow up medical records were received. It was reported that the patient had had induced vaginal delivery with no complications, mild decelerations during delivery. Subsequently, the baby developed rash after receiving ROTATEQ (WAES #0903USA03600). Upon internal review of the file, it was found the baby was born with birthmark back of head. Upon internal review, birthmark back of head was determined to be a congenital anomaly. Follow up information was received from the NUrse Practitionar (N.P) who reported that the birthmark on the patient was a non elevated, beige pigmented area (slightly darker than his skin tone) on the child's left lower leg (previously reported as on the back of the head) measuring a little over 1/2 inch long and 1/4 inch wide. It was reported that the N.P was the child's grandmother and further reported that was seemed to be a family trait as she had a similar birthmark as did her daughter (the child's mother). It was reported that the physician wanted clarification about the baby's birthmark. All medical records are available upon request. This is in follow-up to report (s) previously submitted on 4/14/2009.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gestational diabetes
Clinical narrative: Information has been received for the  pregnancy registry for GARDASIL from a nurse practitioner concerning a 21 year old female with no pertinent medical history, no previous history of pregnancy and no drug reactions/allergies who on 11-JAN-2008 was vaccinated with the first dose of GARDASIL, on 11-MAR-2008 was vaccinated with the second dose of GARDASIL and on 19-JUL-2008 was vaccinated with the third dose of GARDASIL. Concomitant therapy included PHENERGAN 25mg, Q6H for the treatment of nausea, given on 25-JUL-2008. The patient received the complete series of GARDASIL and was pregnant. The patient sought medical attention, in office. The last menstrual period was on 02-JUN-2008. Estimated date of delivery on 09-MAR-2009. Pregnancy was normal to date. Follow-up information has been received which reported that the patient was taking prenatal vitamins as concomitant therapy. The patient experienced gestational diabetes on an unspecified date, as complication during pregnancy. There were no any complications during labor/pregnancy. On 05-MAR-2009, the patient gave birth a healthy baby female at 38 weeks from the last menstrual period, without congenital anomalies or complications. The baby weighted 7 pounds, the length was 19.5 inches and the apgar score was 8/9. No additional information is expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration
Clinical narrative: Initial and follow-up information has been received from a pediatrician, a physician and a registered nurse for the pregnancy registry for GARDASIL concerning a 15 year old female patient who in September 2007 was vaccinated with her first dose of GARDASIL (Lot # 658094/0524U).  On 21-APR-2008, was vaccinated with her second dose of GARDASIL (Lot # 659657/1487U).  The patient became pregnant during her series of vaccination.  No adverse events were reported.  As of 22-AUG-2008 she was at 27 weeks gestation.  In follow-up information the registered nurse reported that the patient with a history of 0 pregnancies and 0 live births who was vaccinated on 18-SEP-2007 with the first dose of GARDASIL (Lot # 658094/0524U) became pregnant on 29-OCT-2008 (EDD 31-OCT-2008 also reported 01-NOV-2008) and on 29-OCT-2008 delivered a normal, healthy male baby weighing 7 pounds 11 ounces.  Follow-up information was received from a health professional who reported that the baby with no known drug allergies was seen at the doctor's office on 05-NOV-2008.  The baby weighted 6 lbs, 15 oz, the length was 20 inches, the head circumference was 31.5 inches and the temperature was 97.2F.  The baby was fed with formula received 2-3 times a day.  The baby did not present any problem with exception that was spitting up a little.  The diagnostic impression indicated a well newborn.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Culture positive, Drug exposure during pregnancy, Laboratory test
Clinical narrative: Information has been received from a certified nurse midwife, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female with asthma, hypersensitivity and no known drug allergies who on 03-JUN-2008 was vaccinated a 0.5 ml dose GARDASIL intramuscularly (lot number and injection route not reported). There was no concomitant medication. Subsequently the patient was found to be pregnant. Unspecified medical attention was sought. The patient's LMP was 30-MAR-2008, and the estimated delivery date is 04-JAN-2009. Follow-up information was received from a registered nurse concerning the 17 year old black female with asthma and obesity who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL (lot number 659005/1522U). Concomitant medications included albuterol and Nasalcrom. On 11-SEP-2008, an ultrasound was performed (result unspecified). On an unspecified date, the patient had a CT culture which was positive. The patient was given Zithromax 1 g xl. On 10-JAN-2009, the patient delivered a female baby, weight 6 lb, 8.5 oz. The nurse reported that the baby was normal with no congenital anomalies and not other complications or abnormalities. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Drug exposure during pregnancy, Headache, Muscle spasms, Pollakiuria
Clinical narrative: Information has been received from a registered nurse (R.N.) for the pregnancy registry for GARDASIL concerning a female patient who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot #, date and route not reported). It was reported that the patient received the second dose of GARDASIL just before finding out she was pregnant. The patient sought medical attention at the office. Follow up information was received from a Registered Nurse (R.N.) concerning a 16 year old white primigravida female patient with history of chickenpox, no known drug allergies and with allergy to dogs and birds, who on 24-NOV-2008 was vaccinated with the first dose of GARDASIL. On 22-JAN-2009 the patient received the second 0.5 ml dose of GARDASIL intramuscularly into the upper right arm. It was reported that the patient received the second dose of GARDASIL when she was pregnancy. Concomitant therapy on 24-NOV-2008 included a 0.5 ml dose of DTP (+) Poliovirus vaccine inactivated (+) Tetanus toxoid intramuscularly into the upper left arm. It was reported that the patient was taking contraceptives pills (unspecified). It was reported that the interval of the menstrual period was 28 days, the duration was normal and the patient had experienced cramps in the past. It was reported that on unspecified date (present pregnancy) the patient experienced cramps, headache and urinary was high frequency. The blood pressure was measured and the result was 102/58. The last menstrual period was on 12-DEC-2008 and the estimated delivery date was on 18-SEP-2008. Family history was reported, hypertension and diabetes (grand mother and grand father), multiple pregnancy (mom). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a registered nurse (R.N.) for the pregnancy registry for GARDASIL concerning a female patient who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot #, date and route not reported). It was reported that the patient received the second dose of GARDASIL just before finding out she was pregnant. The patient sought medical attention at the office. Follow up information was received from a Registered Nurse (R.N.) concerning a 16 year old white primigravida female patient with history of chickenpox, no known drug allergies and with allergy to dogs and birds, who on 24-NOV-2008 was vaccinated with the first dose of GARDASIL. On 22-JAN-2009 the patient received the second 0.5 ml dose of GARDASIL intramuscularly into the upper right arm. It was reported that the patient received the second dose of GARDASIL when she was pregnancy. Concomitant therapy on 24-NOV-2008 included a 0.5 ml dose of DTP (+) Poliovirus vaccine inactivated (+) Tetanus toxoid intramuscularly into the upper left arm. It was reported that the patient was taking contraceptives pills (unspecified). It was reported that the interval of the menstrual period was 28 days, the duration was normal and the patient had experienced cramps in the past. It was reported that on unspecified date (present pregnancy) the patient experienced cramps, headache and urinary was high frequency. The blood pressure was measured and the result was 102/58. The last menstrual period was on 12-DEC-2008 and the estimated delivery date was on 18-SEP-2008. Family history was reported, hypertension and diabetes (grand mother and grand father), multiple pregnancy (mom). Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 9 year old female patient with a history of migraine headaches and no known drug allergies who on 24-FEB-2009 was vaccinated with her first dose of GARDASIL (lot number 661766/0652X, site not reported) by subcutaneous route for prevention of the human papilloma virus. There was no concomitant mediations or past drug history. The nurse reported that the patient was fine, no syncope, and the injection site looked fine. There was no relevant laboratory date. As of 24-FEB-2009, it was unknown if the patient would continue to get GARDASIL injections and the patient was fine. Follow-up information was received from the nurse indicating that the patient was given GARDASIL Subcutaneous in her right arm in error and the patient experienced pain at the injection site which lasted for 2 days. There were no further problems. No further information was available.
Sex: U
Vaccine: HPV4
Symptoms: Abdominal pain upper
Clinical narrative: Information has been received from a radiologist reported that a gastroenterologist said he had some patients experience stomach pain after receiving a dose of GARDASIL. No specific patient information was provided. Follow up information was received from a radiologist by phone on 19-MAR-2009 providing the name and telephone number of the gastroenterologist. This is one of several reports from the same source. 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.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her daughter an 18 year old female with allergy to (unspecified medication) who on 23-FEB-2009 was vaccinated with a "third dose" of GARDASIL. Lot number was not available. Concomitant therapy included MENACTRA. The patient's mother reported her daughter experienced rash, fever, headache and stiffness in her neck on 06-MAR-2009 after receiving her third dose of the vaccine. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema of eyelid, Eyelid oedema
Clinical narrative: Information has been received from a nurse practitioner concerning a 27 year old female with allergy to thimerosal and no medical history who on an unknown date, was vaccinated with GARDASIL (lot # not reported). There was no concomitant medication. "About three weeks ago" (on approximately 9-MAR-2009), the patient developed swollen and slightly red eyelids. An allergy skin test was performed (result unknown). The patient's swollen and slightly red eyelids persisted. The patient sought medical attention by office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a young adult female who was vaccinated with the first dose of GARDASIL (lot number not available) a year ago (in 2008).  One or two weeks after receiving GARDASIL the patient developed systemic allergic reaction in 2008.  She was hospitalized for 7 days (hospital demographic unspecified).  Subsequently, the patient recovered on an unspecified date.  The patient sought unspecified medical attention.  No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who on 20-MAR-2009 was vaccinated with GARDASIL (lot number 659184/0843X) 0.5 ml IM (site not reported). Concomitant therapy included XANAX. On approximately 20-MAR-2009, "a week" ago the patient developed a welt at the injection site. It was unspecified if the patient sought medical attention. The outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history and no known drug allergies/reactions who on 8-AUG-2008 (also reported as 8-AUG-2009) was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot # 659184/0843X). There was no concomitant medication. On 8-AUG-2008 the patient experienced muscle aches near the injection site. No lab diagnostics studies were performed. On 10-AUG-2008 (also reported as 10-AUG-2009) the patient recovered. The patient sought medical attention via going to the office. The patient would be getting the second dose of GARDASIL on 30-MAR-2009 which was late. This is one of several reports from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Influenza like illness, Lymphadenopathy, Muscular weakness
Clinical narrative: Information has been received from a 21 year old female with hypersensitivity to yeast who on 3-MAR-2009 was vaccinated with the first dose of GARDASIL. Concomitant vaccination included hepatitis A vaccine (unspecified) and typhoid vaccine (unspecified). On 17-MAR-2009 the patient experienced weak, swollen glands, muscle weakness and flu like symptoms. The patient's weak and swollen glands and muscle weakness and flu like symptoms persisted. No lab diagnostics study was performed. At the time of reporting the patient had not recovered from the above events. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 27-MAR-2009 was vaccinated with a first dose of GARDASIL (lot # not reported). Concomitant therapy included MENACTRA. Subsequently, the patient experienced dizzy. No lab diagnostics studies were performed. The patient sought unspecified medical attention from the physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Depression
Clinical narrative: Information has been received from a physician assistant concerning a "teenager" female who was vaccinated with GARDASIL 0.5 ml. After getting GARDASIL the patient experienced depression. At the time of reporting, the outcome was not reported. The patient sought unspecified medical attention. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Headache, Wheezing
Clinical narrative: Information has been received from an employee at a physician's office concerning a couple of patients who was vaccinated with GARDASIL. The patients experienced "headaches, wheezing, dizziness and joint pains" after vaccination. It was stated that the vaccine was not administered at the office therefore she could not provide additional information. This is one of several reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from an office administrator concerning a 19 year old female who on 12-JAN-2009 and 18-MAR-2009 was vaccinated with the first and second doses of GARDASIL 0.5ml (lot # not reported). The patient reported her period being 2 weeks late on 30-MAR-2009. The patient sought unspecified medical attention from the physician. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Malaise, Syncope
Clinical narrative: Information has been received from a physician concerning his 22 year old daughter who on 12-Mar-2009 was vaccinated with her first dose of GARDASIL (lot number and site not reported) 0.5ml IM. There was no concomitant medication. On 12-Mar-2009, after receiving the vaccine the patient experienced pain at the injection site and fainted. The patient also did not "feel well" for a few hours after vaccination. On 12-Mar-2009 the patient recovered from pain at the injection site, fainted and did not feel well. Pain at the injection site, fainted and did not feel well were considered to be disabling. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety
Clinical narrative: Information has been received from a RN concerning a 15 year old female patient who on approximately 16-MAR-2009 was vaccinated with the first dose of GARDASIL. It was reported that the patient has been having acute anxiety since. The patient sought unspecified medical attention. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dizziness
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 06-MAR-2009 was vaccinated with GARDASIL IM 0.5ml.  Concomitant therapy included a recent shot of DEPO-PROVERA.  The patient experienced dizziness on 06-MAR-2007, 07-MAR-2009 and 09-MAR-2009.  The physician did not say if there was any dizziness occurring on 08-MAR-2009.  The patient "had to leave school".  The patient sought unspecified medical attention.  Dizziness was considered to be disabling.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Bedridden, Headache, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the second dose of GARDASIL (Lot not reported). Subsequently, the patient experienced fever, headache and was bedridden after receiving the second dose of GARDASIL. The mother of the patient called the clinic. The outcome of the patient was not reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from an office nurse concerning a female who on an unknown date, was vaccinated with the third dose of GARDASIL (lot# not reported). Subsequently the patient was diagnosed with Guillain Barre by a neurologist. Upon internal review, Guillain Barre was considered to be an other important medical event. In follow-up, the nurse revealed that the approximately 22 year old patient received two doses of GARDASIL on 18-JUL-2007 (lot# 658100/0525U) and 20-DEC-2007 (lot# 659439/1267U). Additional information has been requested.  8/26/09  MR rec'd for DOS  5/6-12/2008 with D/C DX:  Guillain-Barre Syndome, s/p 5 days of IVIG.  ADHD.  Pt initially presented to ER with 9 day hx of ascending numbness and weakness to the level of the abdomen. 2 prior ER visits, but presented again with chest pressure, decreased strength, difficulty walking, and worry re: condition. PE (+) for decreased strength and sensation. DTRs trace or absent. Admitted for IVIG.  Pt had autonomic instability with tachycardia and HTN, insomnia, H/A and constipation, somewhat improved by d/c.  Transferred for rehab 5/12/08 ICD9-357.0, 787.20, 349.0,314.01,  9/4/09 Hospital records received DOS 5/23/08 to 6/9/08. Assessment: Guillain-Barre' Syndrome Previous hospital stay complicated by respiratory distress / insufficiency. Transferred and placed on respiratory support (BiPAP). 7 days of plasmapheresis. Dysphagia, PEG tube. Difficulty activating facial muscles. Decreased muscle strength. Deep tendon reflexes absent lower extremities, trace in upper extremities. Anemia. Headache. Discharge to rehabilitation.
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Immediate post-injection reaction, Loss of consciousness, Tooth injury
Clinical narrative: Information has been received from a physician concerning a female who in 2008, "within the past year", was vaccinated with a dose of GARDASIL (lot # not reported). Immediately after vaccination the patient passed out, hit her head and broke a tooth. Patient sought medical attention via an office visit. On an unspecified date the patient recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient who was vaccinated with a dose of GARDASIL (Lot # not reported) 0.5ml.  Patient had a "severe allergic reaction" after received the vaccine and was hospitalized.  The reporter did not know what the "severe allergic reaction" consisted of.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL. It was reported that sometime after she got the vaccine the patient had been having "fainting spells." The patient sought unspecified medical attention and went to an emergency room but was not admitted. The doctor reported that since the patient was continuing to faint then it was a significant disability/incapacity. At the time of reporting the patient was not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with the second dose of GARDASIL (Lot # not provided). After getting the second dose of GARDASIL the patient experienced fainting. Subsequently, the patient recovered from fainting on unspecified date. The reporter stated that the patient had no AE after first dose. It was reported that the patient sought unspecified medial attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 20-JAN-2009 was vaccinated with her first dose of GARDASIL 0.5ml IM, lot number: 661703/0651X.  On approximately "2 or 3 days after vaccination" (22-JAN-2009 or 23-JAN-2009), the patient experienced red rash on her arm from shoulder to hand.  Subsequently, the patient recovered "2 weeks after the vaccination", on approximately 3-FEB-2009.  The patient sought medical attention, she saw the physician.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Drug exposure during pregnancy, Malaise
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with Nail-patella syndrome who in 2008 was vaccinated with the first and second doses of GARDASIL. On 23-FEB-2009 when she was 7 weeks pregnant, the patient was vaccinated with the third dose of GARDASIL. Concomitant medication included birth control pills for one week. Her EED was 26-OCT-2009. This was her first pregnancy. It was reported that the patient was "pretty sick and kind of weak". No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Vaginitis bacterial
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a certified medical assistant concerning a 15 year old female patient who on 23-JAN-2009 received a first dose of GARDASIL and was pregnant.  Concomitant therapy included prenatal vitamins.  The patient's last menstrual period was on 27-DEC-2008 and the estimated delivery date is on 02-OCT-2009.  The patient had no previous pregnancies or full term deliveries.  On approximately 03-MAR-2009, the patient experienced a bacterial vaginosis and was treated with METRONIDAZOLE 500 mg twice a day since 03-MAR-2009.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site discharge, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL. The nurse reported that "right after receiving the second dose" the patient came back to the clinic because she saw a crystallized mass come out from the surface of the injection site. Nurse reported that the patient did not report this kind of issue when she got the first dose of GARDASIL vaccine. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Vaginal haemorrhage
Clinical narrative: Information has been received from a certified medical assistant concerning her 17 year old female friend with no pertinent medical history who in 2008, "several months ago", was vaccinated with the second dose of GARDASIL. There was no concomitant medication. It was reported that the patient was not pregnant. The patient hadn't had her period since. She had occasional spotting that lasted no more than one day. At the time of this report, the patient's symptoms persisted. No lab test were done. The patient did not seek medical attention. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with pertinent medical history or drug allergies/reactions who on 7-JAN-2009 was vaccinated IM with the first dose of GARDASIL and on 9-MAR-2009 was vaccinated IM with the second dose of GARDASIL (lot # : 661703/0651X). There was no concomitant medication. In March 2009, after receiving the second dose, the patient experienced injection site reaction. The patient complained of "puffy arm with redness, itching and burning". At the time of this report , the patient was recovering. The patient called the office for medical attention. Additional information has been requested
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 20 year old female with no relevant medical history, no relevant concomitant medications and no relevant past drug history who on 11-MAR-2009 was vaccinated with the third dose of GARDASIL at about 12:00. The patient did not develop any adverse events after 2 doses of GARDASIL. On 12-MAR-2009, at approximately 02:00 am, the patient woke up with uncontrollable shaking and called the nurse practitioner. The nurse practitioner described the patient as being alert and able to talk. She recommended her to take an unknown dose of BENADRYL. As of 12-MAR-2009, the patient's uncontrollable shaking subsided after she took BENADRYL. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 13 year old female patient who on 16-JUL-2007 was vaccinated with the first dose of GARDASIL, on 14-OCT-2008 received the second dose of GARDASIL (lot # 661044/0548X) and on 13-MAR-2009 was administered IM with a 0.5 ml third dose of GARDASIL. On 13-MAR-2009, approximately 12 minutes after receiving the third dose of GARDASIL vaccine, the patient fainted. The patient was seen by the physician at the practice. On 13-MAR-2009 the patient recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Back pain, Influenza, Urinary tract infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with not sexually active and a history of meningitis as a baby who in August 2008, was vaccinated with the first dose of GARDASIL (Lot# not reported), on 20-OCT-2008, was vaccinated with the second dose of GARDASIL (Lot# not reported). There was no concomitant medication. And the patient had had an unspecified number of urinary tract infections, frequent lower back pain, abdominal pain and got the flu for the first time. The first dose and second dose were given by another unspecified provider's office. Prior to receiving GARDASIL, the patient had "always been healthy all her life" (as reported by the patient's mother). The patient went to emergency room in January 2009 for the flu. The nurse practitioner assumed urine culture and sensitivity test done by another unspecified provider's office. The reporter nurse mentioned although she did not feel the patient's symptoms were related to the GARDASIL, the third dose of GARDASIL would not be given. Subsequently, the patient recovered from unspecified number of urinary tract infections, frequent lower back pain, abdominal pain and flu on unknown date. It was reported that the patient sought medical attention: office visit. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who was vaccinated with complete GARDASIL series. On 13-FEB-2009, the patient had a PAP test, the result showed positive for HPV and had atypical cells during a recent PAP test. The reporter nurse did not know what types of GARDASIL were positive. The patient was not recovered from the adverse events. It was reported that the patient sought medical attentions: seen in office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information hs been received from a physician concerning a female patient who was on unspecified dates was vaccinated with 0.5 ml doses of GARDASIL (lot number, site and route not reported). In January 2008, the patient developed warts on her feet after getting GARDASIL. She sought unspecified medial attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cardiac flutter, Cardiac murmur
Clinical narrative: Information has been received from a nurse concerning a female who patient who on an unspecified date was vaccinated IM with her second 0.5 ml dose of GARDASIL (lot number and site not reported). The day after she got her second dose of GARDASIL, the patient's "heart fluttered", and it happened again "a month later". Her doctor later verified that she had two heart murmurs. The nurse didn't know if the patient had the murmurs before getting vaccinated. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Headache, Insomnia, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her daughter, a 11 year old female patient, with no known drug allergies, joint pain and problems with bones who was vaccinated with her first and second doses of GARDASIL (lot number, site and route not reported) several months ago. There was no concomitant medication. A few months ago, the patient experienced a fever, vomiting, headache, blurred vision, trouble sleeping, chest pain and dizziness. MRI and other unspecified lab work were performed on an unspecified date (no result reported). The events persisted at the time of this report. An unspecified medical attention was sought. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Vision blurred, Vomiting
Clinical narrative: Information has been received from a consumer concerning her daughter, a 11 year old female patient, with no known drug allergies, joint pain and problems with bones who was vaccinated with her first and second doses of GARDASIL (lot number, site and route not reported) several months ago. There was no concomitant medication. A few months ago, the patient experienced a fever, vomiting, headache, blurred vision, trouble sleeping, chest pain and dizziness. MRI and other unspecified lab work were performed on an unspecified date (no result reported). The events persisted at the time of this report. An unspecified medical attention was sought. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female patient with no pertinent medical history and no known drug allergies who on 5-MAR-2009 was vaccinated with the third dose of GARDASIL (lot # not provided). Concomitant therapy included YAZ. On 6-MAR-2009 the patient experienced a fever of 99.8 F to 101F, achiness and headache. No lab diagnostics studies were performed. The patient was treated with MOTRIN. At the time of reporting, the patient was recovering. The patient sought medical attention via an office visit. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Pain, Swelling, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 49 year old female with hypothyroidism and gastroesophageal reflux disease who on 2-MAR-2009 was inadvertently vaccinated IM with a 0.5 ml first dose of GARDASIL (lot # not reported) due to human error. It was reported that the patient was supposed to received a tetanus toxoid vaccination. There was no product confusion involved. Concomitant therapy included omeprazole (MSD), SYNTHROID and vitamins (unspecified). On 3-MAR-2009 the patient experienced pain and swelling in armpit after the vaccination. The patient sought medical attention at the practice. No lab test performed. As of 9-MAR-2009 the patient was recovering. Additional information has been requested,
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning her daughter with eczema and allergies who in June 2008 was vaccinated with the first dose of GARDASIL. On 09-MAR-2009 the patient was vaccinated with her third dose of GARDASIL subcutaneously in the left upper arm. Concomitant therapy included CLARITIN. On 09-MAR-2009 the patient experienced soreness, warmth and redness at the injection site after the vaccination. The reporter added that an unspecified amount of vaccine "run down my daughter's arm" during administration. The patient self treated the injection site reaction with cool compresses and at the time of reporting, 10-MAR-2009, was recovering. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Congenital uterine anomaly, Drug exposure during pregnancy, Ovarian cyst, Pregnancy test positive, Ultrasound scan abnormal
Clinical narrative: Information has been received from a registered nurse for the pregnancy registry for GARDASIL concerning a 23 year old female with asthma and no known drug reactions/allergies, who on 21-JAN-2009 was vaccinated with the first dose of GARDASIL, 0.5ml intramuscularly. Concomitant therapy included albuterol. The registered nurse reported that the patient was pregnant. On an unspecified date, the patient had a positive beta-human chorionic gonadotropin pregnancy test. Date of last menstrual period was on 24-OCT-2008. The estimated delivery date is 31-JUL-2009. The patient sought medical attention and was seen at the practice. Follow-up information was received from a questionnaire completed by a gynecologist indicating that the patient was a female, with cervical dysplasia and with a history of 1 pregnancy, 1 live birth and no pre-term deliveries, spontaneous abortions, elective terminations nor fetal deaths, who on 21-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # 661703/0651X). Concomitant therapy included albuterol. Medications taken during the pregnancy included folic acid and prenatal vitamins. Routine prenatal testing included a routine ultrasound performed on 06-MAR-2009, which detected bicornuate uterus and fluid filled cyst. Follow-up information was received on 19-MAR-2009 from the licensed practical nurse, clarifying that the bicornuate uterus and fluid filled cyst was in the mother and not in the fetus. She also mentioned that it was a left ovarian ovarian fluid filled cyst. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Fatigue, Nausea, Vomiting, Weight decreased
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning her 16 year old daughter with juvenile rheumatoid arthritis, and allergies to BACTRIM, ZITHROMAX, CECLOR, potatoes, tree nuts, peaches, pears and apples who in November 2008 was vaccinated with the first dose of GARDASIL.  There was no concomitant medication.  It was reported that the patient received the first dose of GARDASIL and has been sick for 6-8 weeks.  It was reported that the patient was fatigued, nauseous, vomited, stomach hurt and lost 8 pounds.  It was reported that the patient's stomach hurting was getting better but she was still fatigued and had not gain the 8 pounds of weight back that was lost. No significant disability was reported however the patient has seen three unspecified physicians and has missed school.  A gastrointestinal work up, allergy work and blood work were performed (results not provided).  It was reported that the patient saw the pediatrician on 10-MAR-2009.  It was reported that the patient took one pill of an unspecified "gastrointestinal medication" that gave the patient a bad stomachache.  It was reported that the "gastrointestinal medication may have been PREVACID or gastrointestinal pills (MSD).  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Drug exposure during pregnancy, Fatigue, Pregnancy test positive, Swelling
Clinical narrative: Information has been received from a consumer concerning her 22 year old niece who on approximately 24-FEB-2009 was vaccinated with a dose of GARDASIL (Lot # not reported) 0.5ml, intramuscularly. The patient took an at home pregnancy test a week after she got the vaccine and it was positive. In approximately February 2009, since the patient got the shot, she experienced swelling, tiredness, bloating and tenderness. At the time on the report the patient was not recovered. The patient did not seek medial attention. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness
Clinical narrative: Information has been received from a consumer concerning her 22 year old niece who on approximately 24-FEB-2009 was vaccinated with a dose of GARDASIL (Lot # not reported) 0.5ml, intramuscularly. The patient took an at home pregnancy test a week after she got the vaccine and it was positive. In approximately February 2009, since the patient got the shot, she experienced swelling, tiredness, bloating and tenderness. At the time on the report the patient was not recovered. The patient did not seek medial attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated with her second dose of GARDSIL (lot # not provided). The patient fainted after getting her second dose of GARDASIL. There was no adverse event after the patient received her first and third dose of GARDASIL. The patient had sought unspecified medical attention. On an unspecified date the patient recovered from an adverse event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who in November 2008, was vaccinated IM with a 0,5ml dose of GRADASIL (lot #: 659184/0843X). There was no concomitant medication. 3 days after the vaccination, the patient developed a cold. The patient experienced runny nose but no fever. At the time of this report, the patient was recovered. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a female who in June 2008 and August 2008 was vaccinated with her first and second dose of GARDASIL (lot number, route and site not reported). The patient stated that she experienced injection site soreness each time she was vaccinated with GARDASIL. Each time the pain went away with in 24 hours. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site atrophy, Injection site discolouration, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on unspecified dates in 2007 was vaccinated with the first two doses of GARDASIL, 0.5ml, intramuscularly in the buttocks and in December, 2007 was vaccinated with the third dose of GARDASIL, 0.5ml, intramuscularly in the left arm. The nurse practitioner reported that when the patient was seen in December, 2007, there was an indentation in her buttocks about the size of half dollar and the skin was "caved in". There was no inflammation. The patient was seen again that week. The area on her buttock has increased in severity. The indentation remained. The area was blue-purple in color and tender to touch. At the reporting time, the patient had not recovered. The patient sought medical attention through an office visit. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Dizziness, Feeling hot
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who in approximately September 2008, "4-6 months ago" from the reporting date, was vaccinated with the first dose of GARDASIL, 0.5ml. No lot number was provided. Concomitant therapy included DTAP (unspecified). The physician reported that in approximately September 2008, "4-6 months ago" from the reporting date, the patient experienced warmth and dizziness. At the time of the report, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an approximately 12 year old female who on approximately 6-MAR-2009, "about a week ago" from the reporting date, was vaccinated with the first dose of GARDASIL, 0.5 ml. No lot number was provided. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The physician reported that the patient fainted after receiving her first dose of GARDASIL. It was stated that "about a week ago" from the reporting date, on approximately 6-MAR-2009, the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a "16 years old" female who was vaccinated with a third 0.5 ml dose of GARDASIL (lot # not reported) "4-6 months ago". Subsequently the patient fainted after the vaccination. The patient sought an unspecified medical attention. As of 13-MAR-2009, the patient's outcome was unknown. Additional information has been requested.