chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage, Vulvovaginal mycotic infection
Clinical narrative: Initial and additional information has been received from a 20 year old female with allergy to metals who in April 2011, was vaccinated with a dose of GARDASIL. Secondary therapy included ethinyl estradiol (+) etonogestrel since February 2011 (also reported as 10 months ago) vaginally, "3 weeks in 1 week out", for birth control (duration and dose not reported). On 22-APR-2011, the patient stated she started spotting. The patient reported that she had been using ethinyl estradiol (+) etonogestrel since February 2011 and never experienced irregular bleeding or change in her cycle time. The patient stated that received GARDASIL and in April 2011, a few days ago, two days after receiving GARDASIL she got her period 10 days earlier than she normally would while ethinyl estradiol (+) etonogestrel was still inserted. At the time of this report, the patient had not recovered. The patient reported she was also experiencing vaginal secretion similar to what she felt was a yeast infection. The patient was informed of the PI's information on use of anti-yeast products with the ethinyl estradiol (+) etonogestrel and referred to health care provide. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Chest discomfort, Dyspnoea, Eye swelling, Lip swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with unspecified allergies and no pertinent medical history who "one year ago" in January 2010, was vaccinated with a 0.5 ml first dose of GARDASIL (Lot# not reported), IM, and a dose of AFLURIA (manufacturer unknown). The patient developed fever after receiving her first dose of GARDASIL and AFLURIA (manufacturer unknown). On 18-JAN-2011 the patient was vaccinated with a second 0.5ml dose of GARDASIL (Lot #1664Z), IM, and a dose of FLUZONE. Physician stated that on approximately 19-JAN-2011 the patient's eyes swelled shut, her chest got tight, and her throat felt tight after administration of GARDASIL and FLUZONE during the same visit. The patient was treated with BENADRYL at home. There were no laboratories diagnostic studies performed. The physician examined the patient at the time of the report on 19-JAN-2011 and the patient was feeling better. Follow-up information has been received from the physician who reported that the female patient was vaccinated with 0.5ml first dose of GARDASIL (Lot# not reported), IM , and a dose of AFLURIA (manufacturer unknown). "One year ago" in January 2010, unknown time and experienced fever of 102 degrees F. On 17-JAN-2011 (previously reported as 18-JAN-2011) the patient was vaccinated with a second 0.5ml dose of GARDASIL (Lot# 666163/0664Z, Exp Date 12-SEP-2012) (Lot# previously reported as 1664Z) and a 0.5 ml dose of FLUZONE, IM. Unknown time. The physician stated that on 17-JAN-2011 experienced shortness of breath that lasted 2 days and after the second dose of GARDASIL was administered on approximately 17-JAN-2011 her lips swelled and got 99.6 degrees F of temperature. On 19-JAN-2011 the patient had recovered from these symptoms. No further information is available.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Throat tightness
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with unspecified allergies and no pertinent medical history who "one year ago" in January 2010, was vaccinated with a 0.5 ml first dose of GARDASIL (Lot# not reported), IM, and a dose of AFLURIA (manufacturer unknown). The patient developed fever after receiving her first dose of GARDASIL and AFLURIA (manufacturer unknown). On 18-JAN-2011 the patient was vaccinated with a second 0.5ml dose of GARDASIL (Lot #1664Z), IM, and a dose of FLUZONE. Physician stated that on approximately 19-JAN-2011 the patient's eyes swelled shut, her chest got tight, and her throat felt tight after administration of GARDASIL and FLUZONE during the same visit. The patient was treated with BENADRYL at home. There were no laboratories diagnostic studies performed. The physician examined the patient at the time of the report on 19-JAN-2011 and the patient was feeling better. Follow-up information has been received from the physician who reported that the female patient was vaccinated with 0.5ml first dose of GARDASIL (Lot# not reported), IM , and a dose of AFLURIA (manufacturer unknown). "One year ago" in January 2010, unknown time and experienced fever of 102 degrees F. On 17-JAN-2011 (previously reported as 18-JAN-2011) the patient was vaccinated with a second 0.5ml dose of GARDASIL (Lot# 666163/0664Z, Exp Date 12-SEP-2012) (Lot# previously reported as 1664Z) and a 0.5 ml dose of FLUZONE, IM. Unknown time. The physician stated that on 17-JAN-2011 experienced shortness of breath that lasted 2 days and after the second dose of GARDASIL was administered on approximately 17-JAN-2011 her lips swelled and got 99.6 degrees F of temperature. On 19-JAN-2011 the patient had recovered from these symptoms. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 17-MAY-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot number not reported). On 18-MAY-2011, the patient came to the physician's office because her hands were profoundly swollen due to edema and swelling. The patient had been working with their healthcare provider to determine if the patient should go off therapy. The patient received ZYRTEC and a steroid (name unknown) as treatment for the event. At the time of the report the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date received the full GARDASIL series (Lot #, expire date not reported), 120 mcg, intramuscularly. Physician mentioned that the patient was diagnosed with CIN3 syndrome. Physician indicated that patient was not sexually active. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Vaginal haemorrhage
Clinical narrative: Information has been received from a registered nurse concerning a female patient , who on 19-JAN-2011 was vaccinated with a dose of GARDASIL (Lot # not reported). The nurse reported that the mother of the patient reported that the patient was experiencing vaginal bleeding and a temperature of 102 degrees Fahrenheit. The nurse reported that the mother stated that the interval between patient's menses were normally very regular, and that this bout of vaginal bleeding was approximately 2 weeks earlier than anticipated during the patient's cycle. It was reported that the patient did not receive treatment for the adverse event. The patient sought medical attention via telephone call to immunizing facility. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Capillary disorder, Cyanosis, Hypoaesthesia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a Nurse Practitioner, concerning a 16 year old female patient with no pertinent medical history or drug reactions/allergies, who on 19-JAN-2011 was vaccinated with a dose of GARDASIL (lot #666987/1016Z). There was no concomitant medication. On 20-JAN-2011 the patient experienced Raynaud's phenomenon with numbness, bluing, and slow capillary refill in both hands. The patient called the Nurse Practitioner for medical attention. There was no treatment given for the events. At the time of the report, the patient's outcome was unknown. Follow up information was received from the nurse practitioner concerning the female patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, who on 19-JAN-2011, at 3:45 pm, was vaccinated intramuscularly with the first dose of GARDASIL (lot#666987/1016Z). The nurse stated that on 20-JAN-2011 at 1:00 pm.  the patient's symptoms included numbness, tingling and blue coloration in both hands-fingers, finger stiff and sore, pale to blue not induced by temperature change. It also was reported that the patient never had these symptoms previously. The nurse reported as exam observations: fingers bilaterally pale with bluish hives on distal ends, slow capillary refill, not swelling and ulnar/radial pulse normally bilaterally. No other relevant diagnostic tests were reported. The adverse events required doctor visit. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Paraesthesia, Raynaud's phenomenon, Urticaria
Clinical narrative: Information has been received from a Nurse Practitioner, concerning a 16 year old female patient with no pertinent medical history or drug reactions/allergies, who on 19-JAN-2011 was vaccinated with a dose of GARDASIL (lot #666987/1016Z). There was no concomitant medication. On 20-JAN-2011 the patient experienced Raynaud's phenomenon with numbness, bluing, and slow capillary refill in both hands. The patient called the Nurse Practitioner for medical attention. There was no treatment given for the events. At the time of the report, the patient's outcome was unknown. Follow up information was received from the nurse practitioner concerning the female patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination, who on 19-JAN-2011, at 3:45 pm, was vaccinated intramuscularly with the first dose of GARDASIL (lot#666987/1016Z). The nurse stated that on 20-JAN-2011 at 1:00 pm.  the patient's symptoms included numbness, tingling and blue coloration in both hands-fingers, finger stiff and sore, pale to blue not induced by temperature change. It also was reported that the patient never had these symptoms previously. The nurse reported as exam observations: fingers bilaterally pale with bluish hives on distal ends, slow capillary refill, not swelling and ulnar/radial pulse normally bilaterally. No other relevant diagnostic tests were reported. The adverse events required doctor visit. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Alopecia
Clinical narrative: Information has been received from a consumer concerning her daughter who on approximately 22-JAN-2009 "1-2 years ago", was vaccinated with a dose of GARDASIL (lot # not reported). It was reported that on an unspecified date the consumer's daughter experienced hair loss and a lot of side effects. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female patient who "few days ago" was vaccinated with a first dose of GARDASIL (Lot # not provided), 0.5 ML. Few hours later, the patient started experiencing a really bad headache that has been lasted since. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Lip injury, Syncope
Clinical narrative: Information has been received from a physician concerning an 11 year old female with no medical history or allergies who on an unspecified date, was vaccinated with GARDASIL (lot# not reported). There was no concomitant therapy. On 31-JUL-2010 the patient experienced syncope, fell and split her lip open. Subsequently (in 2010), the patient recovered from syncope, fell and split her lip open. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Skin reaction, Urticaria
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient with no pertinent medical history who on 27-JUL-2010 was vaccinated with the first dose of GARDASIL (lot number not provided). There were no other vaccinations given at the same time. The physician reported that 2 or three days after vaccination (on approximately 29-JUL-2010) the patient experienced generalized rash and urticaria. The patient had been treated with steroids, prednisone and BENADRYL. At the time of the report the patient had not recovered. The patient sought medical attention by an office visit. Follow up information has been received from the physician who reported that the patient experienced delayed hives reaction that started 5 days after the first dose of GARDASIL (on 01-AUG-2010) and progressively worsened despite BENADRYL around the clock. The physician reported that the patient would not be continuing with the series with GARDASIL. At the time of the report the patient's out come was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall, Head injury, Nausea, Suture insertion, Syncope
Clinical narrative: Information has been received from an office staff member concerning a 14 year old male who on 15-JUL-2010 was vaccinated with the first dose of GARDASIL (lot# not reported). After received the vaccination, as he was sitting in the waiting room he felt like he was going to throw up and he was going to walk out the door. He fainted and hit his head on the banister and had to get stitches. Unspecified medical attention was sought. The outcome of the events was unknown. Follow up information has been received from physician concerning a patient with no medical history or drug reactions/allergies and no illness at the time of the vaccination, who on 15-JUL-2010 the first  dose of GARDASIL (Lot # 666121/1778Y), IM in the right arm at 14:00. Concomitant therapy included a first dose of MENACTRA (Lot # U3455AA) IM, into the left arm, given on the same day at 14:00. On 15-JUL-2010 at 14:15, the patient had a syncopal/fainting episode post immunization. The patient fell and hit his forehead on handrail requiring four superficial sutures at dermatologist. No further sequelae was reported. The patient recovered on 15-JUL-2010. There was no diagnostic laboratories studies performed. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has  been received from a nurse concerning an around 14 or 15 year old female patient who a few month ago, on an unspecified date was vaccinated with a second dose of GARDASIL (Lot # unknown). The nurse reported that after the patient received the second dose of GARDASIL started experiencing syncope episodes that persisted for a few months. According to the nurse, the patient was still experiencing dizziness and lightheadedness. The outcome of the syncopes is unclear. At the time of the report, the patient had not recovered from dizziness and lightheadedness. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse concerning an around 14 or15 year old female patient who a few month ago, on an unspecified date was vaccinated with a second dose of GARDASIL (Lot # unknown). The nurse reported that after the patient received the second dose of GARDASIL started experiencing syncope that persisted for a few months. According to the nurse, the patient was still experiencing dizziness and lightheadedness. The outcome of the syncopes is unclear. At the time of the report, the patient had not recovered from dizziness and lightheadedness. The patient sought unspecified medical attention. This is one of several reports received from the same source. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a reporter concerning a 19 year old female with no medical history or drug reactions/allergies who in approximately 2007 (2-3 years ago) was vaccinated with GARDASIL (lot# not reported). There was no concomitant medication. It was reported that the vaccine did not work because in July 2010 the patient experienced contracted the HPV virus. Unspecified medical attention was sought. HPV testing and biopsies were performed. At the time of the report the patient had not recovered. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently, on an unspecified date, the patient experienced extreme pain in her arm that 72 hours after vaccine administration she was still experiencing. The pain was enough to make her cry. There was no swelling. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Human papilloma virus test positive, Prostatic acid phosphatase abnormal, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning an approximately 24 year old female who in 2006 was vaccinated with her second dose of GARDASIL (Lot number unknown) and on 09-AUG-2010 was vaccinated with her third dose of GARDASIL (Lot number unknown). The patient was also having a colposcopy for an abnormal PAP test. The abnormal PAP test revealed high risk HPV. The patient sought medical attention in the office. At the time of the report, the patient had not recovered from abnormal PAP test and high risk HPV. Follow-up information has been received from a registered nurse who indicated that the patient did not receive her 3rd dose of GARDASIL on 09-AUG-2010. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a nurse concerning her "14 year old" daughter who in June 2008, was vaccinated with the first dose of GARDASIL (lot number not provided). In June 2008 the patient completed vaccination with the series of GARDASIL (lot number not provided). There was no concomitant medication. The nurse reported that her daughter was using GARDASIL and experienced alopecia in September 2008. The nurse reported that the patient applied lotion to her scalp and got injections (unspecified). At the time of the report the patient had not recovered. Laboratory tests performed included thyroid testing with no results provided. The patient sought unspecified medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Lymph node pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent medical history and no drug reactions/allergies who in approximately August 2010 (as of 06-AUG-2010 and was reported as at last week), was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (LOT# not reported) and right after getting the vaccine she started experiencing "excruciating pain" at the injection site. She even called the office 48 hours later and was still experiencing it. There was no lab diagnostics studies performed. At this time of reporting, the patient's out come was unknown. Follow-up information has been received from the physician who reported that the female student with no illness at the time of vaccination or adverse events following prior vaccination or pre-existing allergies, birth defects, medical conditions who on 04-AUG-2010 at 02:30 PM was vaccinated intramuscularly at left arm with the first dose of GARDASIL (LOT# 666163/0664Z). On that day, the patient experienced severe arm pain and pain in axillary node for one week following vaccine. The patient was still having pain in arm and also painful node, but not severe three weeks later. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dermatologic examination normal, Fatigue, Gastrointestinal examination normal, Gynaecological examination normal
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 09-AUG-2010 was vaccinated with the first dose of GARDASIL (therapy dose, route and site unknown). The nurse reported that the patient was given the first dose of GARDASIL and within minutes the patient fell asleep. The patient was able to be aroused and she answered questions correctly but then fell right back asleep afterwards. The patient stayed in the office. The nurse states the patient had still not yet awake. Follow-up information has been received from the registered nurse. She reported that the patient had bilateral congenital cholesteatoma and asthma, migraines, motion sickness. The patient had no known drug allergies and did not use tobacco and alcohol. The patient had previously vaccinated influenza virus vaccine (unspecified). On 09-AUG-2010 in the afternoon, at approximately 3:30 pm, the patient was seen at office for White Cell Count ("WCC") and was vaccinated with the first dose of GARDASIL. There was no concomitant medication. After 3 minutes of the vaccination, the patient felt really tired. The patient was lethargized by fatigue and headache. The patient had juice with pretzel. On 09-AUG-2010 the patient presented to the emergency room at 5:40 pm via a wheelchair. Upon arrival she was clam and her headache pain score was assessed at 4/10. Vital signs included body temperature 36.7 C, pulse 98, respiratory 16, blood pressure 111/58, spO2 70. All other body systems were normal. The laboratory tests and results as following: body temperature 36.7 C, pulse 98, respiratory 16, blood pressure 111/58, spO2 70. Other tests including  Respiratory, Neurological, Eye, Gastrointestinal, genitourinary, gynecological, skin and orthopaedic were all normal. The patient was treated with Ibuprofen 600 mg, po, three times a day. The patient had ability to take food and fluid in emergency department. At 7:20 PM, the patient was awake, pleasant and had ginger ale. The patient was re-examined and then was discharged at 7:30 pm. Clinical impression: headache and pre-syncope. The patient was sent home and was improved. The patient was recovered on 10-AUG-2010. Additional information is not requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Lethargy, Neurological examination normal, Ophthalmological examination normal, Orthopedic examination normal
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 09-AUG-2010 was vaccinated with the first dose of GARDASIL (therapy dose, route and site unknown). The nurse reported that the patient was given the first dose of GARDASIL and within minutes the patient fell asleep. The patient was able to be aroused and she answered questions correctly but then fell right back asleep afterwards. The patient stayed in the office. The nurse states the patient had still not yet awake. Follow-up information has been received from the registered nurse. She reported that the patient had bilateral congenital cholesteatoma and asthma, migraines, motion sickness. The patient had no known drug allergies and did not use tobacco and alcohol. The patient had previously vaccinated influenza virus vaccine (unspecified). On 09-AUG-2010 in the afternoon, at approximately 3:30 pm, the patient was seen at office for White Cell Count ("WCC") and was vaccinated with the first dose of GARDASIL. There was no concomitant medication. After 3 minutes of the vaccination, the patient felt really tired. The patient was lethargized by fatigue and headache. The patient had juice with pretzel. On 09-AUG-2010 the patient presented to the emergency room at 5:40 pm via a wheelchair. Upon arrival she was clam and her headache pain score was assessed at 4/10. Vital signs included body temperature 36.7 C, pulse 98, respiratory 16, blood pressure 111/58, spO2 70. All other body systems were normal. The laboratory tests and results as following: body temperature 36.7 C, pulse 98, respiratory 16, blood pressure 111/58, spO2 70. Other tests including  Respiratory, Neurological, Eye, Gastrointestinal, genitourinary, gynecological, skin and orthopaedic were all normal. The patient was treated with Ibuprofen 600 mg, po, three times a day. The patient had ability to take food and fluid in emergency department. At 7:20 PM, the patient was awake, pleasant and had ginger ale. The patient was re-examined and then was discharged at 7:30 pm. Clinical impression: headache and pre-syncope. The patient was sent home and was improved. The patient was recovered on 10-AUG-2010. Additional information is not requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Sudden onset of sleep
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 09-AUG-2010 was vaccinated with the first dose of GARDASIL (therapy dose, route and site unknown). The nurse reported that the patient was given the first dose of GARDASIL and within minutes the patient fell asleep. The patient was able to be aroused and she answered questions correctly but then fell right back asleep afterwards. The patient stayed in the office. The nurse states the patient had still not yet awake. Follow-up information has been received from the registered nurse. She reported that the patient had bilateral congenital cholesteatoma and asthma, migraines, motion sickness. The patient had no known drug allergies and did not use tobacco and alcohol. The patient had previously vaccinated influenza virus vaccine (unspecified). On 09-AUG-2010 in the afternoon, at approximately 3:30 pm, the patient was seen at office for White Cell Count ("WCC") and was vaccinated with the first dose of GARDASIL. There was no concomitant medication. After 3 minutes of the vaccination, the patient felt really tired. The patient was lethargized by fatigue and headache. The patient had juice with pretzel. On 09-AUG-2010 the patient presented to the emergency room at 5:40 pm via a wheelchair. Upon arrival she was clam and her headache pain score was assessed at 4/10. Vital signs included body temperature 36.7 C, pulse 98, respiratory 16, blood pressure 111/58, spO2 70. All other body systems were normal. The laboratory tests and results as following: body temperature 36.7 C, pulse 98, respiratory 16, blood pressure 111/58, spO2 70. Other tests including  Respiratory, Neurological, Eye, Gastrointestinal, genitourinary, gynecological, skin and orthopaedic were all normal. The patient was treated with Ibuprofen 600 mg, po, three times a day. The patient had ability to take food and fluid in emergency department. At 7:20 PM, the patient was awake, pleasant and had ginger ale. The patient was re-examined and then was discharged at 7:30 pm. Clinical impression: headache and pre-syncope. The patient was sent home and was improved. The patient was recovered on 10-AUG-2010. Additional information is not requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who in approximately August 2010, was vaccinated with a dose of GARDASIL (LOT# not reported). "Yesterday", on approximately 09-AUG-2010 the patient experienced fainted. Unspecified medical attention was sought. At this time of reporting, the patient's outcome was unknown. Follow-up information has been received from the registered nurse who reported that the 17 year old female student with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions and no adverse event following prior vaccination who on 09-AUG-2010 was vaccinated intramuscularly at right deltoid with the first dose of GARDASIL (LOT# 662304/1013Y). On the same day at 10:00 AM, the patient fainted after receiving injection. The patient recovered on the same day. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a certified medical assistant concerning her 12 year old daughter with no pertinent medical history drug reactions or allergies who in 2008, was vaccinated with a dose of GARDASIL (Lot# unknown). There was no concomitant medication. In 2008, after received GARDASIL, the patient developed headache that resolved shortly after receive MOTRIN. The patient sought medical attention with the certified medical assistant. Follow up information has been received from the medical assistant concerning her daughter with no illness at time of vaccination. The medical assistant initially reported that on 08-AUG-2010, her daughter had been vaccinated subcutaneously in the left arm with a second dose of VARIVAX (Merck). However, this information was clarified by herself stating that her daughter did not have any adverse event on VARIVAX (Merck) and that her daughter had received GARDASIL (Lot# 660389/1968U) and subsequently experienced a headache, which she recovered from. There were no laboratory tests or diagnostic studies reported. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone, Borrelia test, Full blood count, Hypoaesthesia, Metabolic function test
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with sports induced asthma and sulfonamide allergy who on 07-JUN-2010 was vaccinated with the first dose of GARDASIL  (Lot# 663599/1178Y), 0.5 ml, IM in her left deltoid. Concomitant therapy included oral contraceptives (unspecified). On 07-JUN-2010 the patient experienced numbness in one finger and leg. She had been examined by a neurologist and was scheduled to have a MRI (magnetic resonance imaging) and computed axial tomography (CAT) scan of spine. The patient had comprehensive metabolic panel, thyroid-stimulating hormone (TSH) level, B12 level, Lyme, complete blood count performed (results not reported). At the time of the report, the patient had not recovered from numbness in one finger and leg. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Vitamin B12
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with sports induced asthma and sulfonamide allergy who on 07-JUN-2010 was vaccinated with the first dose of GARDASIL  (Lot# 663599/1178Y), 0.5 ml, IM in her left deltoid. Concomitant therapy included oral contraceptives (unspecified). On 07-JUN-2010 the patient experienced numbness in one finger and leg. She had been examined by a neurologist and was scheduled to have a MRI (magnetic resonance imaging) and computed axial tomography (CAT) scan of spine. The patient had comprehensive metabolic panel, thyroid-stimulating hormone (TSH) level, B12 level, Lyme, complete blood count performed (results not reported). At the time of the report, the patient had not recovered from numbness in one finger and leg. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who "approximately 7 weeks ago", on approximately 12-MAY-2010 was vaccinated with the first 0.5ml dose of GARDASIL in the deltoid. Subsequently the patient experienced nausea, vomiting and body aches. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female patient with penicillin allergy who on 01-MAY-2009 and 04-AUG-2009 respectively, was vaccinated IM with with first and second 0.5 ml doses of GARDASIL (Lot# of first dose: unknown) (Lot# of second dose: 663451/0216Y) (Expiration date: 17-SEP-2010). The medical assistant reported that on 04-AUG-2009 the patient experienced dizziness and fainting. The patient did not seek medical attention. At the time of the report, the patient had recovered from dizziness and fainting (date unknown). Additional information has been requested.
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Headache, Pyrexia
Clinical narrative: Information has been received from a female clinic employee concerning her daughter who in approximately July 2008, was vaccinated with a dose of GARDASIL (lot# not reported) and a dose of tetanus toxoid (lot# and manufacturer unknown). In approximately July 2008, the patient developed a 105 degree Fahrenheit fever and a bad headache within 30 minutes following the vaccinations. The fever and headache lasted a few hours and the patient consulted a physician via phone call, who instructed her to manage the fever with TYLENOL and ice packs. At the time of this report, the patient had fully recovered. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Information has been received from a register nurse concerning a 25 year old female patient with no known drug allergies or no other pertinent medical history who on 27-APR-2010 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot# 663559/1178Y) into her left deltoid. Concomitant therapy included YAZ. On 28-APR-2010 the patient experienced entire hand and feet were red, hot and swollen after receiving GARDASIL. The patient sought unspecified medical attention. No laboratory studies were performed. The patient's symptoms resolved after a few days. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Gaze palsy, Hyperhidrosis, Hypotonia
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history or allergies who on 03-SEP-2009 and 24-JUN-2010, was vaccinated IM with the first (lot# 661046/0381X, expiration date 01-DEC-2010) and the second (lot# 662529/1317Y, expiration date 30-MAY-2011) doses of GARDASIL, 0.5 mL, respectively. There was no concomitant medication. The patient did not have any problems after the first dose of GARDASIL. On 24-JUN-2010, 5-10 minutes after standing up and ready to go, the patient got dizzy, fell, and half minute later stiffened and hand clenched. The patient was diaphoretic and pale. The patient's blood pressure was 110/70 with a pulse of 80. On 24-JUN-2010, the patient recovered from the events. The patient sought medical attention in the office. In follow up, the physician indicated that 10 minutes post the second dose of GARDASIL, the patient stated she "felt dizzy", then went limp and lost consciousness. The patient also experienced stiffening of extremities and eye rolling. The events lasted about 1.5 minutes, was not past one day. This is an amended report. "Vaccinated at Private doctor's office/hospital" and "Vaccine purchased with private funds" had been selected for the second dose of GARDASIL. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no medical history or allergies who on 03-SEP-2009 and 24-JUN-2010, was vaccinated IM with the first (lot# 661046/0381X, expiration date 01-DEC-2010) and the second (lot# 662529/1317Y, expiration date 30-MAY-2011) doses of GARDASIL, 0.5 mL, respectively. There was no concomitant medication. The patient did not have any problems after the first dose of GARDASIL. On 24-JUN-2010, 5-10 minutes after standing up and ready to go, the patient got dizzy, fell, and half minute later stiffened and hand clenched. The patient was diaphoretic and pale. The patient's blood pressure was 110/70 with a pulse of 80. On 24-JUN-2010, the patient recovered from the events. The patient sought medical attention in the office. In follow up, the physician indicated that 10 minutes post the second dose of GARDASIL, the patient stated she "felt dizzy", then went limp and lost consciousness. The patient also experienced stiffening of extremities and eye rolling. The events lasted about 1.5 minutes, was not past one day. This is an amended report. "Vaccinated at Private doctor's office/hospital" and "Vaccine purchased with private funds" had been selected for the second dose of GARDASIL. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Abdominal pain, Menstruation irregular, Vaginal haemorrhage
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient with a history of regular menstrual cycles who on 17-JUN-2010 was vaccinated with the first dose of GARDASIL 0.5 mL IM. there was no concomitant medication. On 19-JUN-2010, the patient developed irregular menstrual bleeding. The patient's irregular menstrual bleeding persisted. The patient sought medical attention, at office visit. Follow up information has been received from a physician concerning a female patient with no pertinent medical history, no pre-existing allergies and no illness at the time of vaccination who was vaccinated with first dose of GARDASIL. Concomitant therapy included a dose of ADACEL and varicella virus vaccine live (manufacturer unspecified) (route and dose not reported). The physician reported that on 19-JUN-2010, the patient experienced abnormal vaginal bleeding and abdominal cramping that began 2 days after she received her first dose of GARDASIL. It resulting in 2 office visits. The patient started on DESOGEN, oral administration to control the bleeding. It was unknown if the patient had recovered from abdominal cramping and abnormal vaginal bleeding. There were no laboratory diagnostics tests performed. The patient sought medical attention, at office visit. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who was vaccinated intramuscularly with three doses of GARDASIL (lot#s not reported) with schedule as 2 months, 4 months and 6 months. On an unknown date, the patient came back for Papanicolaou test and it presented with C1N1. Unspecified medical attention was sought. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who on unspecified dates was vaccinated a three 0.5 ml dose series of with GARDASIL. The patient recently came back to the office and tested positive for HPV. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, who was not the treating physician, concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, on an unknown date the patient fainted after receiving GARDASIL. It was unknown if the patient sought medical attention. At the time of the report, the patient was recovering. The physician did speak with said "this has already been reported". Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 18 years old female patient with drug hypersensitivity to Ibuprofen and no medical history, who on an unspecified date was vaccinated with the second dose of GARDASIL (Lot # unspecified). There was no concomitant medication. The nurse reported that three days after received the second dose of GARDASIL, the patient experienced bilateral arm rash. The nurse mentioned that the rash resolved after one week. Lab diagnostics were not performed. No medication was prescribed. The patient sought medical attention by the visit to the physician's office. Follow-up information has been received from a registered nurse concerning a 18 year old student female who on an unspecified date was vaccinated with a second dose of GARDASIL. The nurse reported that the patient possibly experienced a rash on bilateral dorsal forearms that developed 3 days after vaccination. Reporter also stated that vaccine was given by another provider, no vaccine was administered by her clinic. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician who received a letter on 11-JUN-2010 from an Ob/Gyn who concerning an 18 year old female with no pertinent medical history or no drug reactions or allergies who on 13-MAY-2009 was vaccinated IM with the first standard dose of GARDASIL. The second dose was vaccinated on 02-JUL-2009 and the third dose on 14-APR-2010. There was no concomitant medication. Subsequently the patient tested positive in the Pap smear even though the patient received 3 series doses of GARDASIL. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no pertinent medical history or no drug reactions or allergies who on 20-APR-2010 was vaccinated IM with the first dose of GARDASIL (663551/1495Y). Concomitant therapy included YAZ. Subsequently the patient was testing for "high risk" for HPV. The patient sought unspecified medical attention. The patient had not received further doses yet. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Emotional disorder, Injection site induration, Injection site mass, Injection site pain, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female patient with sulfa allergy and a history of dysmenorrhoea who was vaccinated intramuscularly with three 0.5 ml doses of GARDASIL (lot#s for dose one and dose two not reported. Lot# for dose three 663559/1178Y) into the left deltoid respectively on 01-MAY-2009, 21-JUL-2009 and 18-MAY-2010. Concomitant therapy included YAZ. On 11-JUN-2010 the patient developed a gold ball size lump on her left arm which was painful to the touch with no bruising after receiving the third dose of GARDASIL. On 15-JUN-2010, the office received a phone call from the patient and the physician's recommendations were to use ice and ADVIL. On 21-JUN-2010 the patient called back and was still complaining about the arm pain. On 22-JUN-2010 the patient came in to see the physician. She was examined. There was a 2cm induration on the left upper arm which was very tender. There was no discoloration. Patient was able to move her arm. She was very upset. At the time of this report, the patient had not recovered. Follow up information has been received from the licensed practical nurse concerning the 20 year old female patient who on 18-MAY-2010, at 9:30, was vaccinated intramuscularly with the third dose of GARDASIL (lot # 663559/1178Y) into the left upper arm. On 11-JUN-2010 the patient called to report a golf ball size lump on her left arm with no bruising. The patient was instructed to use ice and ADVIL. On 21-JUN-2010 the patient called back and still reported some problem. On 22-JUN-2010 the patient came in to see the physician. She was examined. There was a 2cm induration with no erythema on the left upper arm which was very tender. Patient was able to move her arm. She was recommended pain medications, ice or hot. She was very upset with her condition. She declined pain medications. At the time of this report, the patient's outcome was not reported. Follow up information has been received from a nurse practitioner who reported that on 01-SEP-2010 the patient was called. She still had grape size tender lump at injection site which was tender to touch and pain with exercise. The pain was relieved with ibuprofen. The patient stated that there was no change in status for a while. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female patient with sulfa allergy and a history of dysmenorrhoea who was vaccinated intramuscularly with three 0.5 ml doses of GARDASIL (lot#s for dose one and dose two not reported. Lot# for dose three 663559/1178Y) into the left deltoid respectively on 01-MAY-2009, 21-JUL-2009 and 18-MAY-2010. Concomitant therapy included YAZ. On 11-JUN-2010 the patient developed a gold ball size lump on her left arm which was painful to the touch with no bruising after receiving the third dose of GARDASIL. On 15-JUN-2010, the office received a phone call from the patient and the physician's recommendations were to use ice and ADVIL. On 21-JUN-2010 the patient called back and was still complaining about the arm pain. On 22-JUN-2010 the patient came in to see the physician. She was examined. There was a 2cm induration on the left upper arm which was very tender. There was no discoloration. Patient was able to move her arm. She was very upset. At the time of this report, the patient had not recovered. Follow up information has been received from the licensed practical nurse concerning the 20 year old female patient who on 18-MAY-2010, at 9:30, was vaccinated intramuscularly with the third dose of GARDASIL (lot # 663559/1178Y) into the left upper arm. On 11-JUN-2010 the patient called to report a golf ball size lump on her left arm with no bruising. The patient was instructed to use ice and ADVIL. On 21-JUN-2010 the patient called back and still reported some problem. On 22-JUN-2010 the patient came in to see the physician. She was examined. There was a 2cm induration with no erythema on the left upper arm which was very tender. Patient was able to move her arm. She was recommended pain medications, ice or hot. She was very upset with her condition. She declined pain medications. At the time of this report, the patient's outcome was not reported. Follow up information has been received from a nurse practitioner who reported that on 01-SEP-2010 the patient was called. She still had grape size tender lump at injection site which was tender to touch and pain with exercise. The pain was relieved with ibuprofen. The patient stated that there was no change in status for a while. Additional information has been requested.