chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Information has been received from a female patient who was a medical assistant and a physician concerning the patient who was vaccinated with her first dose of GARDASIL (lot number not available) on an unspecified date. Subsequently the patient developed a stiff neck after receiving the first dose of GARDASIL on an unspecified date. She recovered 3 days after injection. The patient sought unspecified medical attention. Follow up information was received from the 21 year old patient (medical assistant) who was vaccinated with her first dose of GARDASIL (lot #660616/0570X) on 18-FEB-2009. There were no concomitant vaccines or medications. She had no pertinent medical history other than an allergy to penicillin. The AE onset date was 19-FEB-2009. The condition was not disabling. According to the patient, she wasn't sure if the event had anything to do with the vaccine and indicated that she could have just slept wrong. The patient was planning on receiving her second dose of GARDASIL in April 2009 and would report if she again experienced a stiff neck. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Computerised tomogram abnormal, Nephrolithiasis, Ovarian cyst, Pain
Clinical narrative: Information has been received from a registered nurse concerning her daughter who 02-FEB-2009 was vaccinated with her third dose of GARDASIL (lot number, route and site not reported). Concomitant therapy included Allegra. The dates of the first two doses of GARDASIL were unknown. 2 weeks after receiving the first dose. The patient began having pain that has been "on and off ever since". On 02-FEB-2009 the patient had a transvaginal ultrasound that was negative. The patient's pain was so serve that on the night of 10-APR-2009. On Friday night she was seen in the emergency room due to the lower right quadrant pain. The patient had a computed tomography scan completed that were both negative. The patient was discharged home from the emergency room. At the time of reporting she was recovering. Additional information was received a nurse practitioner concerning the 25 year old patient who on 01-AUG-2008, 03-OCT-2008 and 02-FEB-2009 was vaccinated with the first (lot number 660553/0070X), second (lot number 660618/0572X) and third (661764/0650X) dose of GARDASIL (route and site not reported). Concomitant therapy included hormonal contraceptives (unspecified). The patient had no complaints following the first dose. On 17-OCT-2008 the patient complained of lower abdominal pain since the second dose of vaccination. The Nurse Practitioner felt the event was unrelated to GARDASIL. The patient had normal bowel movements and an ultrasound was performed that showed a few cysts on the ovaries but nothing else. The patient had apparently started birth control pills, not prescribed by the nurse practitioner, in December 2008 and stopped them at the end of January 2009. She was not aware the patient had recently been to the emergency room and had a CT scan which showed kidney stones. The nurse practitioner will try to find out where the patient was treated and obtain additional patient details. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test negative, Ultrasound scan abnormal, Urine analysis normal
Clinical narrative: Information has been received from a registered nurse concerning her daughter who 02-FEB-2009 was vaccinated with her third dose of GARDASIL (lot number, route and site not reported). Concomitant therapy included Allegra. The dates of the first two doses of GARDASIL were unknown. 2 weeks after receiving the first dose. The patient began having pain that has been "on and off ever since". On 02-FEB-2009 the patient had a transvaginal ultrasound that was negative. The patient's pain was so serve that on the night of 10-APR-2009. On Friday night she was seen in the emergency room due to the lower right quadrant pain. The patient had a computed tomography scan completed that were both negative. The patient was discharged home from the emergency room. At the time of reporting she was recovering. Additional information was received a nurse practitioner concerning the 25 year old patient who on 01-AUG-2008, 03-OCT-2008 and 02-FEB-2009 was vaccinated with the first (lot number 660553/0070X), second (lot number 660618/0572X) and third (661764/0650X) dose of GARDASIL (route and site not reported). Concomitant therapy included hormonal contraceptives (unspecified). The patient had no complaints following the first dose. On 17-OCT-2008 the patient complained of lower abdominal pain since the second dose of vaccination. The Nurse Practitioner felt the event was unrelated to GARDASIL. The patient had normal bowel movements and an ultrasound was performed that showed a few cysts on the ovaries but nothing else. The patient had apparently started birth control pills, not prescribed by the nurse practitioner, in December 2008 and stopped them at the end of January 2009. She was not aware the patient had recently been to the emergency room and had a CT scan which showed kidney stones. The nurse practitioner will try to find out where the patient was treated and obtain additional patient details. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia facial
Clinical narrative: Information has been received from a physician assistant concerning a 21 year old female with no medical history or drug allergies who was vaccinated with the first (661044/0548X) and the second (659655/0940X) dose of GARDASIL IM, 0.5 ml, on 27-JAN-2009 and 08-APR-2009 respectively. Concomitant therapy included unspecified birth control pills. "a couple of days ago" the patient experienced numbness on the felt side of the nose to upper left lip. The second dose was given IM in the left deltoid. The patient did not have any problems after the first dose. No adverse effect reported. The patient did not have any lab diagnostics studies performed. At the time of the report the patient was not recovered. The patient sought medical attention by phone. Follow-up information has been received from a physician assistant who did not know the onset date as the patient did not mention it to her. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Complement factor increased, Rash generalised, Syphilis test, Syphilis test positive
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with a history of cardiac murmur who on 07-APR-2009 was vaccinated with the first dose of GARDASIL (lot # 661952/1129X), IM, 0.5ml.  There was no concomitant medication.  On 09-APR-2009 the patient experienced a rash that appeared and disappeared all over her body after receiving GARDASIL.  The nurse described the rash as similar to mosquito bites in appearance but not raised or pruritic.  The nurse stated that after reporting this incident she received lab results  for the patient that were drawn on 07-APR-2009 and the patient was positive for syphilis.  She stated that the physician assistant believed the rash was from the syphilis and not the GARDASIL injection.  At time of the report the patient was recovering.  The patient sought medical attention by office visit.  Follow up information has been received from the physician assistant who stated that the rash was not raised or red.  The patient's RPR (rapid plasma regain) screening test for syphilis was positive.  The TPPA (Treponema pallidum particle agglutination assay) confirmatory test was positive with an assigned titer level of 1:64, which was considered high.  The patient was placed on V-CILLIN K, one dose weekly for three weeks.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with asthma and no known drug allergies who on 27-JUN-2008, 26-NOV-2008 and 13-APR-2009 was vaccinated with first dose (dose, route and lot number not reported), second dose (dose, route and lot number not reported) and third 0.5mL dose (route intramuscular, lot number 661531/1311X), respectively of GARDASIL.  Concomitant therapy included "birth
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female who on an unspecified dates was vaccinated with the three doses of GARDASIL (dose, route and lot numbers not reported). The registered nurse reported that the patient who completer the series of the vaccine was experiencing missed periods and changes in menstrual cycle. No lab studies were performed. At the time of reporting the patient had not recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient who in approximately January 2009 (reported as about 3 months ago), was vaccinated with the second dose of GARDASIL (Lot number not reported). After getting the second dose, the patient fainted. On an unspecified date, the patient recovered. On an unspecified date the patient received the first dose of GARDASIL and did not experience any adverse event. Follow-up information has been received from a registered nurse concerning a 24 year old female patient (previously reported as 17 years old) with anxiety "when labs are drawn or when she receives an injection", who on an unspecified date was vaccinated with 0.5 ml of the first dose of GARDASIL (Lot number 660620/0571X), intramuscularly in the deltoid muscle. The patient had a vasovagal response after she received the first dose (not after the second dose as previously reported). The patient had recovered. The patient had received the second dose of GARDASIL (date not reported). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling
Clinical narrative: Initial information was received from a physician, and follow up information from a nurse concerning a female patient who was vaccinated with her second (also reported the first dose) dose of GARDASIL (lot number and site not reported) 0.5 ml IM. Subsequently, the patient experienced swelling at the site of injection. The area was about the size of an egg. The swelling lasted for 2 weeks. The patient had recovered from swelling at the site of injection. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a Licensed Visiting Nurse concerning a 12 year old patient who on 03-APR-2009 was vaccinated with the first dose of GARDASIL. The patient was vaccinated with a second dose of GARDASIL on 06-JUN-2008 and the third dose was given on 06-AUG-2008. No adverse reactions were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Myalgia, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient who "last year" in 2008 was vaccinated with her second dose of GARDASIL IM. The patient "myalgia, dizziness and serious fever in the 24 hours after the vaccine". The patient did not have an experience after the first dose. The patient had sought unspecified medical attention. "within 24 hours of vaccination"  the patient recovered from myalgia, dizziness and serious fever. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with no relevant medical history or drug allergies who on 04-NOV-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not reported). Concomitant therapy included vitamins (unspecified). The patient sought an unspecified medical attention. The patient's LMP was estimated to 07-JUN-2008 and the estimated delivery date was 14-MAR-2009. It was reported that the patient had an uncomplicated pregnancy and delivered a health infant, at 36 weeks gestation. Follow-up information was received on 20-APR-2009 from a registered nurse who reported that on 04-NOV-2008 the patient was vaccinated with a first dose of GARDASIL (lot # 661764/0650X). It was unknown if the patient received concomitant vaccines on 04-NOV-2008. Follow-up information was received from a R.N. who reported that the lot # for the first dose of GARDASIL was 660553/0070X (not 661764/0650X as previously reported). It was reported that the patient also received a dose of influenza virus vaccine (unspecified) on 11-NOV-2008 that had a lot # of AFLUA375AA. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nervousness, Syncope
Clinical narrative: Information has been received from a physician assistant concerning a 16 year old female with negative medical history who on 13-APR-2009 received the first dose of GARDASIL IM in the arm (Lot #660618/0572X). There are no concomitant vaccines or medications. On 13-APR-2009 after receiving the first dose, the patient experienced syncope 5 minutes. Subsequently, the patient recovered by the time she left the physician's office. The physician assistant reported that it was unknown if the patient had eaten that morning, but the patient was nervous because her sister had told her the shot would really hurt. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Motion sickness, Vision blurred
Clinical narrative: Information has been received from a physician assistant concerning a 29 year old female patient who on 13-APR-2009 was vaccinated with GARDASIL IM. On 14-MAR-2009 night the patient experienced dizziness. The patient felt so bad that she went sleep and was better when she woke up. "Today" after working out, it came back. The patient was also having headaches that felt like migraines. The patient "currently" being seen at her physician's office. At the time of reporting the patient's dizziness and headaches felt like migraines persisted. Follow-up information has been received from the administration staff in the physician's office that on 14-APR-2009 the patient was vaccinated with her first dose of GARDASIL (lot # 658271/0558X) IM. The patient did not receive any other doses. There was a phone consultation on 15-APR-2009 when the patient complained of motion sickness and blurry vision. The patient came in on 15-APR-2009 and complained of dizziness and headaches. The doctor suggested taking EXCEDRIN MIGRAINE or TYLENOL for the headaches. No medications were dispensed. The patient was not hospitalized. The office had not heard back from the patient at this time. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Laryngitis, Weight increased
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a pregnancy registry product, concerning a 16 year old female who on 03-JUN-2008 was vaccinated with the first dose of GARDASIL IM (lot#658563/1063U). The nurse reported the patient was in the office on 03-JUN-2008 for a physical and her blood pressure was ok, however she had gained 30 pounds in 1 year. The patient's weight was 256 pounds at the time of visit. On 25-AUG-2008 the patient was vaccinated with the second dose of GARDASIL IM (lot# 660553/0070X). On 27-JAN-2009 the patient was vaccinated with the third dose of GARDASIL IM (lot# 660553/0080X). The patient was seen on 25-MAR-2009 for laryngitis, her blood pressure was 157/115 in one arm and 146/91 in the other arm. She was prescribed Bactrim and told to come back in 2 weeks for a follow up on her blood pressure-no treatment was noted. She was 307 pounds at this time and she reported her "last menstrual period" started on 24-MAR-2009. She never made it back in for the two week follow up as she delivered a baby on 09-APR-2009 in her bathroom. The patient went to the hospital after delivery. She had no knowledge of any complications, or any congenital anomalies, she heard the baby weighted over 9 pounds, she received no prenatal care. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Malaise
Clinical narrative: Information has been received from an office manager who stated that she received this report from the patient's mother. The patient's mother had read about this report in a blog e-mail concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number, site and route not reported). It was reported that the patient got sick and not able to go to school after she received GARDASIL. The outcome was not reported. The office manager could not confirm that this was a true report as the patient was not a patient of the physician at the office and she did not have a copy of the e-mail. The patient had sought unknown medical attention. Attempts to verify the existence of an identifiable patient have been unsuccessful. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Dizziness, Fall, Immediate post-injection reaction, Muscle contractions involuntary
Clinical narrative: Information has been received from a physician assistant and nurse concerning a 17 year old female who on 25-DEC-2008 was vaccinated with the first dose of GARDASIL (lot# 661764/0650X) 0.5 ml at 15:00 PM. About 10 second after receiving GARDASIL, the patient was dizzy and fell to the ground. Her muscles in her left arm, where she got the vaccine, locked up. When she stood up she was confused. She was observed for about an hour however did not have any injuries from falling to the ground. The only thing she ate during the day before hand was a "small slice of pizza". The patient recovered from the events on the same day. Follow-up information was received from the licensed practical nurse. The student was vaccinated with the first dose of GARDASIL IM into the left deltoid using aseptic technique in the afternoon on 26-NOV-2008 (previously reported as 26-DEC-2008). Within 1 minute post injection, the patient was getting up from exam table and stated "I am dizzy". She fell to the left side of bed and had the back of her head on floor, left arm contractured and bilateral myoclonus lasting about 20 seconds. The patient was confused upon awakened. The patient was given BENADRYL 25mg and monitored for 1 hour. The mother was advised to check neuro status every 2 hours. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Myoclonus
Clinical narrative: Information has been received from a physician assistant and nurse concerning a 17 year old female who on 25-DEC-2008 was vaccinated with the first dose of GARDASIL (lot# 661764/0650X) 0.5 ml at 15:00 PM. About 10 second after receiving GARDASIL, the patient was dizzy and fell to the ground. Her muscles in her left arm, where she got the vaccine, locked up. When she stood up she was confused. She was observed for about an hour however did not have any injuries from falling to the ground. The only thing she ate during the day before hand was a "small slice of pizza". The patient recovered from the events on the same day. Follow-up information was received from the licensed practical nurse. The student was vaccinated with the first dose of GARDASIL IM into the left deltoid using aseptic technique in the afternoon on 26-NOV-2008 (previously reported as 26-DEC-2008). Within 1 minute post injection, the patient was getting up from exam table and stated "I am dizzy". She fell to the left side of bed and had the back of her head on floor, left arm contractured and bilateral myoclonus lasting about 20 seconds. The patient was confused upon awakened. The patient was given BENADRYL 25mg and monitored for 1 hour. The mother was advised to check neuro status every 2 hours. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Flushing, Headache, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with KEFLEX allergy and irregular heartbeat who on 30-MAR-2009 was intramuscularly vaccinated with the first 0.5 ml dose of GARDASIL (lot # 659182/1757U). On 06-APR-2009 the patient experienced facial flushing, intermittent nausea, intermittent headache and continued exhaustion. At the time of reporting, the patient did not recover. Follow-up information was received from the nurse practitioner who reported the patient had received the first dose of GARDASIL. The reporter stated that she had spoken with the patient over the phone on 21-APR-2009. The patient stated that she had fully recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Clinical narrative: Information has been received from consumer concerning  her 17 year old daughter who"2 or 3 months ago" was vaccinated with the first dose of GARDASIL and on 13-Apr-2009 received the second dose of HPV vaccine. On 13-APR-2009, soon after the second dose of HPV vaccine was given, hives appeared in her mouth and all over her body. The patient's mother reported that her daughter has bumps everywhere including her tongue, gums, roof of her mouth, anywhere there is skin she has bumps.  The bumps are itchy.  It was also reported that the patient's mother had spoken with the physician who believed it is a viral response due to the HPV vaccine.  The physician put the patient on amoxicillin but it does not seem to be helping.  The patient's mother stated that her daughter did not have an experience after the first dose of HPV vaccine was given.  In follow-up the patient's physician reported that she does not believe the HPV vaccine is responsible for the patient's hives.  At the time of reporting, the patient had not recovered.  Follow-up information was received from a physician who reported that the patient, a white 16 years old student with a history of tonsillectomy and adenoidectomy in 1996, was vaccinated in the right arm with the second dose of HPV vaccine (lot # 661531/1311x on 13-APR-2009 at 2:00 pm.  It was reported that the rash onset was on 14-APR-2009 (previously reported per mother as 13-APR-2009) and that it was not hives.  The physician stated that she did not feel this was related to vaccination.  The final outcome was not reported.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Nausea, Rash
Clinical narrative: Information has been received from a physician and his office manager concerning a 25 year old female with a history of bladder repair in July 2007 during which blood transfusions were required and breast implantation in March 2008 and no known drug allergies, who on 11-APR-2009 was vaccinated with first 0.5mL dose of GARDASIL (route not reported, lot number 0074Y). There were no other vaccines administered that date. On 13-APR-2009, the patient experienced foot rash (also reported as rash in the left leg) and nausea. The patient recovered from nausea after four days (17-APR-2009). On 21-APR-2009, the patient came into the office. During that visit only a little redness was remaining on her leg. The medical assistant considered this event as recovering since the patient was directed to her general practitioner for allergy treatment. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Body temperature increased, Heart rate increased, Influenza serology negative, Injection site reaction
Clinical narrative: Information has been received via medical record from a registered nurse concerning a 16 year old female with heavy menstrual periods (last menstrual period approximately on 01-MAR-2009) and a history of osteomyelitis who on 20-MAR-2009 was vaccinated with GARDASIL (lot no. dose and route not reported). On 22-MAR-2009 the patient went to emergency room complaining of fever, itching, back pain and neck pain. Pain was level 5 (scale 1-10). A physical exam was performed which revealed tenderness in back and warm skin. Vital signs: blood pressure 120/72, temperature 99, oxygen saturation 97%, pulse 108. The patient was treated with MOTRIN 800mg, via oral. Laboratory work included an influenza swab and a rapid strep swab, both of which were negative. Vital signs when discharged: blood pressure 110/60, temperature 99, oxygen saturation 99%, heart rate 72, respiratory rate 18 and level of pain 2-3. The patient was diagnosed with GARDASIL side reaction. On 17-APR-2009 a physician reported that no drug reaction was observed on the patient. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Oxygen saturation, Pruritus, Pyrexia, Respiratory rate increased
Clinical narrative: Information has been received via medical record from a registered nurse concerning a 16 year old female with heavy menstrual periods (last menstrual period approximately on 01-MAR-2009) and a history of osteomyelitis who on 20-MAR-2009 was vaccinated with GARDASIL (lot no. dose and route not reported). On 22-MAR-2009 the patient went to emergency room complaining of fever, itching, back pain and neck pain. Pain was level 5 (scale 1-10). A physical exam was performed which revealed tenderness in back and warm skin. Vital signs: blood pressure 120/72, temperature 99, oxygen saturation 97%, pulse 108. The patient was treated with MOTRIN 800mg, via oral. Laboratory work included an influenza swab and a rapid strep swab, both of which were negative. Vital signs when discharged: blood pressure 110/60, temperature 99, oxygen saturation 99%, heart rate 72, respiratory rate 18 and level of pain 2-3. The patient was diagnosed with GARDASIL side reaction. On 17-APR-2009 a physician reported that no drug reaction was observed on the patient. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin warm, Streptococcal identification test negative, Tenderness
Clinical narrative: Information has been received via medical record from a registered nurse concerning a 16 year old female with heavy menstrual periods (last menstrual period approximately on 01-MAR-2009) and a history of osteomyelitis who on 20-MAR-2009 was vaccinated with GARDASIL (lot no. dose and route not reported). On 22-MAR-2009 the patient went to emergency room complaining of fever, itching, back pain and neck pain. Pain was level 5 (scale 1-10). A physical exam was performed which revealed tenderness in back and warm skin. Vital signs: blood pressure 120/72, temperature 99, oxygen saturation 97%, pulse 108. The patient was treated with MOTRIN 800mg, via oral. Laboratory work included an influenza swab and a rapid strep swab, both of which were negative. Vital signs when discharged: blood pressure 110/60, temperature 99, oxygen saturation 99%, heart rate 72, respiratory rate 18 and level of pain 2-3. The patient was diagnosed with GARDASIL side reaction. On 17-APR-2009 a physician reported that no drug reaction was observed on the patient. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix normal, Genital discomfort, Genital herpes, Genital swelling, Smear cervix abnormal
Clinical narrative: Information has been received from an office assistant and a female patient who on 19-MAR-2009 was vaccinated the first dose of GARDASIL. Concomitant therapy included (LEXAPRO). After received her first dose of GARDASIL (LOT# not reported) she experienced genital irritation and swelling. She saw doctor and had a pap test was performed on 31-MAR-2009, results "come back as genital herpes". The event was not disability of life threatening and did not require hospitalization. She also stated that all other tests came back negative before GARDASIL was ever administered. At the time of the report the patient's condition persisted and the patient was treated with LEXAPRO. Additional information will be provided if available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Fall, Head injury, No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a registered nurse and a licensed practical nurse from patient's report and emergency room (ER) records concerning a 16 year old female with CECLOR allergy who was vaccinated with the 1st and 2nd doses of GARDASIL (1st lot #661764/0650X, 2nd lot #661531/1311X) on 15-DEC-2008 and 16-FEB-2009, respectively. She did not have problems on the first dose of GARDASIL. There was no concomitant medication. No other vaccines were given on 16-APR-2009. Additional information received from a nurse indicated that on 16-FEB-2009, the patient experienced an episode of syncope and fell down and got hurt on her head after getting GARDASIL. The patient went to ER on 16-FEB-2009 at 19:45 where a CT of the head was normal. She was given TYLENOL, MOTRIN for pain and released. Event was not disabling or life threatening and did not require in-patient hospitalization. The patient had recovered by the time of the 20-FEB-2009 office visit. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Corneal scar, Visual impairment
Clinical narrative: Initial and follow-up information has been received from a licensed nurse practitioner concerning a female patient who on an unknown date was vaccinated with the first dose of GARDASIL and now was complaining of vision problems. It was reported that the patient's mother called the office and told her daughter's physician that she experienced scarring of cornea after the first GARDASIL vaccination. The nurse practitioner stated that the patient was vaccinated with GARDASIL vaccine in her pediatrician office and not in her gynecologist's office. It is unknown if the patient received the second dose of GARDASIL vaccine. The final outcome was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician and a licensed visiting nurse, concerning a 11 year old female patient, who on 13-AUG-2008 was vaccinated with the first dose of GARDASIL (Lot #655604/0052X) in the left deltoid; on 27-OCT-2008, was vaccinated with the second dose of GARDASIL (Lot # 661530/0575X), in the left deltoid. Concomitant therapy included the second dose of hepatitis A vaccine (inactive) (manufacturer unknown) given in the right arm and varicella virus vaccine live (manufacturer unknown) given in the left arm. In approximately December 2008, 3 to 4 months before the date the patient was seen by the physician (10-MAR-2009), the patient experienced intermittent numbness in the right arm. The patient was not hospitalized. The patient was still experiencing mild, intermittent numbness in right arm. The patient was seen by a neurologist. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Activities of daily living impaired, Fatigue, Full blood count, Haemoglobin decreased, Headache
Clinical narrative: Information has been received from a Allergy Technician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who on 14-NOV-2008 was vaccinated with a first dose of GARDASIL (Lot # 656049/0187U) 0.5ml, intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified). On approximately 05-DEC-2008 the patient experienced fatigue and headaches. The patient was a basketball player and she could not participate in some recent drills. The patient had a schedule appointment to see a cardiologist on 06-MAY-2009. On 09-JAN-2009 the following diagnostics laboratory test were performed: Completed blood cell count (CBC), blood hemoglobin test (HGB): 11.7 was low, Lymphatic percentage: 47.2 was high and lymphatic number: 3.2 was high. At the time on the report on 17-APR-2009 the patient had not recovered. The patient sought medical attention was at office. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Lymphocyte count increased, Lymphocyte percentage increased
Clinical narrative: Information has been received from a Allergy Technician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who on 14-NOV-2008 was vaccinated with a first dose of GARDASIL (Lot # 656049/0187U) 0.5ml, intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified). On approximately 05-DEC-2008 the patient experienced fatigue and headaches. The patient was a basketball player and she could not participate in some recent drills. The patient had a schedule appointment to see a cardiologist on 06-MAY-2009. On 09-JAN-2009 the following diagnostics laboratory test were performed: Completed blood cell count (CBC), blood hemoglobin test (HGB): 11.7 was low, Lymphatic percentage: 47.2 was high and lymphatic number: 3.2 was high. At the time on the report on 17-APR-2009 the patient had not recovered. The patient sought medical attention was at office. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from a medical assistant concerning an unknown number of patients whom were vaccinated with a dose of GARDASIL that was improperly stored. The vaccines were exposed to 31 degrees F on several occasions since January 2009. No adverse effect reported. Follow up information received on 29-APR-2009 from the medical assistant stated that the cup for the temperature gauge was place too close to the vent for a couple of hours. The incident only happened once sometime in January 2009. When the cup was moved to another part of the refrigerator the gauge was reading fine. 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. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Pericarditis, Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with three doses of GARDASIL (Lot # not reported). After first dose she had a fainting spell and she recovered. Approximately a month after she received third dose of GARDASIL she started to experience heart palpitations. The patient saw a cardiologist and was diagnosed with pericarditis. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nasopharyngitis, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received for the Merck pregnancy registry of GARDASIL from a 22 year old female patient with iodine allergy and a history of "precancer for uterus diagnosed on 2003 or 2004" who on 16-FEB-2009 was vaccinated with the first dose of GARDASIL in her primary care physician's office. It was reported that the patient did not received the second dose of GARDASIL because after a urine pregnancy test conducted in the office, it was determined that she was pregnant. The patient noted that no pregnancy test was done prior to her getting the 1st dose of GARDASIL vaccine. The patient's last menstrual period was reported as the beginning of March 2009. However the patient's primary care physician thinks she got pregnant around 5-FEB-2009 and that she was already pregnant when she received the first dose of GARDASIL. The patient mentioned she had colds right now that she developed one or two weeks ago. The patient sought medical attention with her primary care physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pharyngitis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated with the first, second and third doses of GARDASIL. The patient developed pharyngitis about ten days after she received the first, second and third doses of GARDASIL. The patient was seen by the physician. It was reported that on an unspecified date the patient recovered from pharyngitis. Follow up information has been received form a physician's assistant. She reported that the patient developed pharyngitis following each of the three doses of GARDASIL. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Tachycardia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with first 0.5mL dose of GARDASIL (route and lot number not provided). The physician reported that the patient experienced tachycardia after receiving the dose. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a medical coordinator concerning an 18 year old female  who on 25-MAR-2009 was vaccinated with the first dose of GARDASIL (lot no. 661952/1129X) (route not reported).  On 25-MAR-2009, five minutes after the shot, the patient passed out and hit her head.  The medical coordinator heard the bang and treated the patient immediately.  The patient administered smelling salts, the doctor examined the patient, but the patient complained of a headache so the patient was taken to the hospital via ambulance.  The patient was kept in the hospital for a few hours for observation but discharged her the same day.  The patient was not admitted.  The medical coordinator reported the patient's status was 'recovered' but this is only an assumption because they had not heard back from the patient's family.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician and the physician's office manager concerning a 19 year old female who on 23-MAR-2009 was vaccinated with her first and only dose of GARDASIL (LOT # 658563/1063U) intramuscularly. There were no other vaccines administered at the time of vaccination. Concomitant therapy included birth control pills (unspecified). On 23-MAR-2009, after vaccination the patient developed fever of 103 degrees F. On 27-MAR-2009, the patient recovered from fever of 103 degrees F. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female who on an unspecified date was vaccinated with first 0.5 mL dose of GARDASIL (route and lot number mot reported). The nurse practitioner reported that the patient experienced joint pain in her hands. The nurse also reported that the patient did finish the series of GARDASIL. however she was complaining about pain in her hands. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dysplasia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL IM. On an unspecified date the patient had a pelvic exam and it showed that the patient developed "dysplasias". It was unknown if this was after the first, second or third dose. The patient had sought unspecified medical attention. The outcome of the patient's "dysplasias" was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling of body temperature change, Hot flush, Nausea
Clinical narrative: Information has been received from a Registered Nurse concerning a 25 year old female who in 2006 ("3 years ago") was vaccinated with her first and only dose of GARDASIL IM. There was no concomitant medication. On the same day after the vaccination, the patient experienced nausea along with hot and cold flashes. No lab diagnostic study was performed. The patient didn't seek medical attention. On an unspecified date the patient recovered from the above events. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Placenta praevia, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy registry for GARDASIL, concerning a 22 year old female with no pertinent medical history who on 22-Feb-2007 was vaccinated with the first dose of GARDASIL (lot#: 655617/14477), on 22-Apr-2008 was vaccinated with the second dose (lot#:660389/1968U) and on 16-Dec-2008 was vaccinated with the third dose (lot# 660616/0570x). Concomitant therapy included prenatal vitamins and dose of levonorgestrel (Plan B) on 15-Dec-2008. On an unspecified date in 2009 the patient had an ultrasound confirming the pregnancy and revealed a marginal placenta previa. The due date was calculated to be 09-Oct-2009, making the LMP approximately 02-Jan-2009 (the patient's LMP was unknown). The nurse reported that the pregnancy was normal to date. the patient was seen in the office. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 22-JAN-2009 was vaccinated with her first dose of GARDASIL. On 09-APR-2009 the patient was vaccinated with her second dose of GARDASIL. The patient developed a headache, vomiting and achiness after receiving her second dose of vaccine. It was also reported that the patient had a similar response when she received her first dose of vaccine. The patient had sought unspecified medical attention. The symptoms following the second dose resolved "after a couple of days" in April 2009. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Cervical dysplasia, Colposcopy, Human papilloma virus test positive, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no drug reactions or allergies who in 2008 was vaccinated with two doses of GARDASIL. There was no concomitant medication. The physician reported that on 21-APR-2009 the patient had cervical dysplasia and was testing positive for a high risk strain of GARDASIL. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Follow up information has been received from a physician concerning a patient with history of GARDASIL with cervical dysplasia in 2002. In April 2009, the patient had a PAP with HPV. A colposcopy with biopsies was performed and they were awaiting the results. The physician felt that the patients with history of high risk HPV or history of dysplasia, once given GARDASIL, will show HPV with PAP within approximately one year of vaccination with GARDASIL. She felt GARDASIL was distracting the immune system which had previously been "Keeping the lid on" dormant HPV. The physician thought GARDASIL was more appropriate for those not yet sexually active. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning three patient who were vaccinated with GARDASIL and tested positive for a high risk strain of HPV. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous
Clinical narrative: Information hs been received from a nurse practitioner concerning a 14 year old female student with no pertinent medical history and no known drug allergies who on 22-SEP-2008 at 16:00, was vaccinated with the first dose of GARDASIL (lot # 660616/0570X) into her right deltoid. There was no illness at time of vaccination. On 23-SEP-2008 AM the patient experienced bilateral lower extremity red raised rash. No lab diagnostic studies were performed. One week later, the patient recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Syncope, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 11 year old female with bronchospasm exercise induced who n 21-APR-2009 was vaccinated with 0.5 mL first dose of GARDASIL (lot # 661764/0650X). Concomitant therapy included MENACTRA (lot # U2866AA), ADACEL (lot # UF455BA) and a rescue inhaler. The patient experienced syncope after the GARDASIL vaccine. The patient was given water and supportive care. The physician caught her or she would have fallen. The patient experienced a true syncope episode complete with blurry vision. Her vitals were normal when left and she was considered recovered on the same date. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Expired drug administered, Fall, Hypotonia, Loss of consciousness, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 11 year old female with bronchospasm exercise induced who n 21-APR-2009 was vaccinated with 0.5 mL first dose of GARDASIL (lot # 661764/0650X). Concomitant therapy included MENACTRA (lot # U2866AA), ADACEL (lot # UF455BA) and a rescue inhaler. The patient experienced syncope after the GARDASIL vaccine. The patient was given water and supportive care. The physician caught her or she would have fallen. The patient experienced a true syncope episode complete with blurry vision. Her vitals were normal when left and she was considered recovered on the same date. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from a registered nurse, concerning a female who was vaccinated with GARDASIL that was stored improperly at 32 F. No adverse effect noted. The patient sought medical attention at the nurse's office. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 19 year old sexually active female who from 10-JUL-2007 was vaccinated with all three doses of GARDASIL. GARDASIL beginning on 10-JUL-2007 and the other dates were not reported (the lot number of the third dose was reported as 659055/1522U). In approximately April-2009 the patient underwent a pap smear test and the result was "high risk". Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Malaise
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no medical history and allergies, who on 17-APR-2009 was vaccinated with a first dose of GARDASIL. There was no concomitant medication. On 20-APR-2009 the patient started to experience headache, dizziness and did not feel well over her body. No laboratories studies performed. Consumer is unsure if the patient was going to receive the rest of the series. The patient had not recovered. The consumer reported that she had called the patient's physician regarding her experience. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a patient who unspecified date was vaccinated with GARDASIL (lot # not reported). On unspecified date the patient had generalized body aches and pain. No further information is available.