chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 20 year old female patient with an allergic reaction to Z-PACK and a history of migraines who on 10-FEB-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 659437/1266U). On 07-JUL-2009 the patient received the second IM, 0.5 ml dose of GARDASIL (lot number 662404/0312Y) and within one hour of the injection she developed a migraine that lasted for 24 hours. Concomitant therapy included TYLENOL. The patient called the office that day and told the nurse that she "was too sick to come back in". The patient was seen for a follow up appointment 2 days later, on 12-JUL-2009, and "she was fine". There were no lab diagnostics studies performed. Follow up information has been received from a Registered nurse who reported that the female patient who on 7-JUL-2009 was vaccinated IM with a second dose of GARDASIL (lot # 662404/0312Y) at 11:30 a.m into the left arm. The Registered nurse reported that on 07-JUL-2009, the patient experienced migraines, nausea, sore and numb arm at 12:30 p.m. At the time of the report, the patient recovered on 09-JUL-2009 (also reported by Registered nurse as 08-Jul-2009). Additional information is not expected requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Crohn's disease
Clinical narrative: Information has been received from a physician concerning a 21 year old female who in July 2007, was vaccinated with a first dose of GARDASIL. Last week the patient was diagnosed with Crohn's disease. The patient was placed on an unspecified dose of steroids. The patient sought unspecified medical attention. Follow up information received on 21-JUL-2009 from a registered nurse indicated that on 30-JUL-2007 the patient was vaccinated with the first dose of GARDASIL (lot # 657737/0522U). The patient had not received the second or third dose of GARDASIL. The patient was recently diagnosed with Crohn's disease. Follow up information was received from a certified medical assistant and a physician who indicated that on 30-JUL-2007 the female student was vaccinated with the first dose of GARDASIL (lot # 657737/0522U) in the left deltoid at 11:00 am. The patient developed Crohn's disease in 2009. The patient had a family history. The reporters wanted to know if the patient could got the second dose of GARDASIL while on treatment for the Crohn's disease, which was immunosuppressive. It was reported that there was no adverse symptoms from GARDASIL. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Blood bilirubin increased, Drug exposure during pregnancy
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a pharmacist concerning her 23 year old daughter with no pertinent medical history and no drug reactions/allergies who on 24-NOV-2008 was vaccinated the first "standard dose" of GARDASIL. The second dose of GARDASIL was vaccinated on 24-JAN-2009 and the third dose of GARDASIL was vaccinated on 23-APR-2009. Concomitant therapy included birth control pill. The patient received GARDASIL and became pregnant. The last menstrual period was on 29-APR-2009. The patient delivered a female baby on 03-FEB-2010. The apgar score of the baby was 9. On an unspecified date, the baby experienced elevated bilirubin and was resolved within 1 week. The mother's experience has been captured in WAES# 0907USA00774. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased
Clinical narrative: Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The pharmacist reported that patient received one or two doses of GARDASIL, experienced a 104F temperature. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Antinuclear antibody negative, Borrelia test negative, C-reactive protein decreased, Crying
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a family history of cancer following mononucleosis who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid arm. Concomitant therapy included CONCERTA, ZYRTEC and montelukast sodium (MSD). The physician reported that on 23-JUN-2009, was seen in the physician's office with fatigue, left shoulder pain and a lump in her neck. The patient also had nausea but a good appetite. The physician believed there was lymph involvement. Blood tests were performed, complete blood cell count (CBC), streptococcal and a mononucleosis. The results test were normal. The patient was seen at the physician's office again (date unspecified), and patient's the lump was smaller, hard but still mobile. The patient also had a sore throat, stuffy nose, red eyes and shoulder pain. The shoulder had full range of movement but the patient had such pain with movement that she cried. It was noted that the lump on her neck was still visible. On 07-JUL-2007 the patient visited the physician's office and the physician reported that the shoulder pain, sore throat and fatigue had resolved. It was reported that the enlarged supraclavicular node was still palpable at about 1 cm, but non-tender. Follow up information has been received who reported that the 16 year old female with a rash allergy to amoxicillin, seasonal allergies and no adverse events following prior vaccination a who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid (lot number: 662300/0100Y) in the afternoon. Concomitant therapy included CONCERTA 36 mg, ZYRTEC, montelukast sodium (MSD). The patient was reported as a well child. On 23-JUN-2009, the patient developed left shoulder pain and a lump in left side of her neck (supraclavicular area) with 1 day of duration, tired, sore throat, stomach ache and headache. Physical was negative except for left supraventricular lymph node. On 30-JUN-2009 the patient developed sore throat, left shoulder pain, lump was sore and felt harder. She was tired, had malaise and she could not move her left arm. And left shoulder pops and hurts. She was treated with naproxen. It was reported that on 07-JUL-2009 the lump was smaller in size and did not hurt any more. On 10-AUG-2009 the lymph node was small but still palpable. On unspecified dates the following laboratory tests were performed : two rapid streptococcal, serum antinuclear antibodies test and mononucleosis test and lyme disease test all with negative results. Complete blood cell count (CBC) was within normal limits at 8.6 (14.5/41.8), 247 erythrocyte sedimentation rate (ESR) (41), serum C-reactive protein test (CRP) low and complete metabolic panel (CMP) was within normal limits. Additional information is no expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus test negative, Fatigue, Full blood count normal, Headache, Influenza A virus test negative
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a family history of cancer following mononucleosis who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid arm. Concomitant therapy included CONCERTA, ZYRTEC and montelukast sodium (MSD). The physician reported that on 23-JUN-2009, was seen in the physician's office with fatigue, left shoulder pain and a lump in her neck. The patient also had nausea but a good appetite. The physician believed there was lymph involvement. Blood tests were performed, complete blood cell count (CBC), streptococcal and a mononucleosis. The results test were normal. The patient was seen at the physician's office again (date unspecified), and patient's the lump was smaller, hard but still mobile. The patient also had a sore throat, stuffy nose, red eyes and shoulder pain. The shoulder had full range of movement but the patient had such pain with movement that she cried. It was noted that the lump on her neck was still visible. On 07-JUL-2007 the patient visited the physician's office and the physician reported that the shoulder pain, sore throat and fatigue had resolved. It was reported that the enlarged supraclavicular node was still palpable at about 1 cm, but non-tender. Follow up information has been received who reported that the 16 year old female with a rash allergy to amoxicillin, seasonal allergies and no adverse events following prior vaccination a who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid (lot number: 662300/0100Y) in the afternoon. Concomitant therapy included CONCERTA 36 mg, ZYRTEC, montelukast sodium (MSD). The patient was reported as a well child. On 23-JUN-2009, the patient developed left shoulder pain and a lump in left side of her neck (supraclavicular area) with 1 day of duration, tired, sore throat, stomach ache and headache. Physical was negative except for left supraventricular lymph node. On 30-JUN-2009 the patient developed sore throat, left shoulder pain, lump was sore and felt harder. She was tired, had malaise and she could not move her left arm. And left shoulder pops and hurts. She was treated with naproxen. It was reported that on 07-JUL-2009 the lump was smaller in size and did not hurt any more. On 10-AUG-2009 the lymph node was small but still palpable. On unspecified dates the following laboratory tests were performed : two rapid streptococcal, serum antinuclear antibodies test and mononucleosis test and lyme disease test all with negative results. Complete blood cell count (CBC) was within normal limits at 8.6 (14.5/41.8), 247 erythrocyte sedimentation rate (ESR) (41), serum C-reactive protein test (CRP) low and complete metabolic panel (CMP) was within normal limits. Additional information is no expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza virus test negative, Joint crepitation, Laboratory test normal, Lymphadenopathy, Malaise
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a family history of cancer following mononucleosis who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid arm. Concomitant therapy included CONCERTA, ZYRTEC and montelukast sodium (MSD). The physician reported that on 23-JUN-2009, was seen in the physician's office with fatigue, left shoulder pain and a lump in her neck. The patient also had nausea but a good appetite. The physician believed there was lymph involvement. Blood tests were performed, complete blood cell count (CBC), streptococcal and a mononucleosis. The results test were normal. The patient was seen at the physician's office again (date unspecified), and patient's the lump was smaller, hard but still mobile. The patient also had a sore throat, stuffy nose, red eyes and shoulder pain. The shoulder had full range of movement but the patient had such pain with movement that she cried. It was noted that the lump on her neck was still visible. On 07-JUL-2007 the patient visited the physician's office and the physician reported that the shoulder pain, sore throat and fatigue had resolved. It was reported that the enlarged supraclavicular node was still palpable at about 1 cm, but non-tender. Follow up information has been received who reported that the 16 year old female with a rash allergy to amoxicillin, seasonal allergies and no adverse events following prior vaccination a who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid (lot number: 662300/0100Y) in the afternoon. Concomitant therapy included CONCERTA 36 mg, ZYRTEC, montelukast sodium (MSD). The patient was reported as a well child. On 23-JUN-2009, the patient developed left shoulder pain and a lump in left side of her neck (supraclavicular area) with 1 day of duration, tired, sore throat, stomach ache and headache. Physical was negative except for left supraventricular lymph node. On 30-JUN-2009 the patient developed sore throat, left shoulder pain, lump was sore and felt harder. She was tired, had malaise and she could not move her left arm. And left shoulder pops and hurts. She was treated with naproxen. It was reported that on 07-JUL-2009 the lump was smaller in size and did not hurt any more. On 10-AUG-2009 the lymph node was small but still palpable. On unspecified dates the following laboratory tests were performed : two rapid streptococcal, serum antinuclear antibodies test and mononucleosis test and lyme disease test all with negative results. Complete blood cell count (CBC) was within normal limits at 8.6 (14.5/41.8), 247 erythrocyte sedimentation rate (ESR) (41), serum C-reactive protein test (CRP) low and complete metabolic panel (CMP) was within normal limits. Additional information is no expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test, Mononucleosis heterophile test negative, Movement disorder, Musculoskeletal pain, Nasal congestion
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a family history of cancer following mononucleosis who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid arm. Concomitant therapy included CONCERTA, ZYRTEC and montelukast sodium (MSD). The physician reported that on 23-JUN-2009, was seen in the physician's office with fatigue, left shoulder pain and a lump in her neck. The patient also had nausea but a good appetite. The physician believed there was lymph involvement. Blood tests were performed, complete blood cell count (CBC), streptococcal and a mononucleosis. The results test were normal. The patient was seen at the physician's office again (date unspecified), and patient's the lump was smaller, hard but still mobile. The patient also had a sore throat, stuffy nose, red eyes and shoulder pain. The shoulder had full range of movement but the patient had such pain with movement that she cried. It was noted that the lump on her neck was still visible. On 07-JUL-2007 the patient visited the physician's office and the physician reported that the shoulder pain, sore throat and fatigue had resolved. It was reported that the enlarged supraclavicular node was still palpable at about 1 cm, but non-tender. Follow up information has been received who reported that the 16 year old female with a rash allergy to amoxicillin, seasonal allergies and no adverse events following prior vaccination a who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid (lot number: 662300/0100Y) in the afternoon. Concomitant therapy included CONCERTA 36 mg, ZYRTEC, montelukast sodium (MSD). The patient was reported as a well child. On 23-JUN-2009, the patient developed left shoulder pain and a lump in left side of her neck (supraclavicular area) with 1 day of duration, tired, sore throat, stomach ache and headache. Physical was negative except for left supraventricular lymph node. On 30-JUN-2009 the patient developed sore throat, left shoulder pain, lump was sore and felt harder. She was tired, had malaise and she could not move her left arm. And left shoulder pops and hurts. She was treated with naproxen. It was reported that on 07-JUL-2009 the lump was smaller in size and did not hurt any more. On 10-AUG-2009 the lymph node was small but still palpable. On unspecified dates the following laboratory tests were performed : two rapid streptococcal, serum antinuclear antibodies test and mononucleosis test and lyme disease test all with negative results. Complete blood cell count (CBC) was within normal limits at 8.6 (14.5/41.8), 247 erythrocyte sedimentation rate (ESR) (41), serum C-reactive protein test (CRP) low and complete metabolic panel (CMP) was within normal limits. Additional information is no expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Neck mass, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a family history of cancer following mononucleosis who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid arm. Concomitant therapy included CONCERTA, ZYRTEC and montelukast sodium (MSD). The physician reported that on 23-JUN-2009, was seen in the physician's office with fatigue, left shoulder pain and a lump in her neck. The patient also had nausea but a good appetite. The physician believed there was lymph involvement. Blood tests were performed, complete blood cell count (CBC), streptococcal and a mononucleosis. The results test were normal. The patient was seen at the physician's office again (date unspecified), and patient's the lump was smaller, hard but still mobile. The patient also had a sore throat, stuffy nose, red eyes and shoulder pain. The shoulder had full range of movement but the patient had such pain with movement that she cried. It was noted that the lump on her neck was still visible. On 07-JUL-2007 the patient visited the physician's office and the physician reported that the shoulder pain, sore throat and fatigue had resolved. It was reported that the enlarged supraclavicular node was still palpable at about 1 cm, but non-tender. Follow up information has been received who reported that the 16 year old female with a rash allergy to amoxicillin, seasonal allergies and no adverse events following prior vaccination a who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid (lot number: 662300/0100Y) in the afternoon. Concomitant therapy included CONCERTA 36 mg, ZYRTEC, montelukast sodium (MSD). The patient was reported as a well child. On 23-JUN-2009, the patient developed left shoulder pain and a lump in left side of her neck (supraclavicular area) with 1 day of duration, tired, sore throat, stomach ache and headache. Physical was negative except for left supraventricular lymph node. On 30-JUN-2009 the patient developed sore throat, left shoulder pain, lump was sore and felt harder. She was tired, had malaise and she could not move her left arm. And left shoulder pops and hurts. She was treated with naproxen. It was reported that on 07-JUL-2009 the lump was smaller in size and did not hurt any more. On 10-AUG-2009 the lymph node was small but still palpable. On unspecified dates the following laboratory tests were performed : two rapid streptococcal, serum antinuclear antibodies test and mononucleosis test and lyme disease test all with negative results. Complete blood cell count (CBC) was within normal limits at 8.6 (14.5/41.8), 247 erythrocyte sedimentation rate (ESR) (41), serum C-reactive protein test (CRP) low and complete metabolic panel (CMP) was within normal limits. Additional information is no expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate increased, Streptococcus test, Streptococcus test negative
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a family history of cancer following mononucleosis who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid arm. Concomitant therapy included CONCERTA, ZYRTEC and montelukast sodium (MSD). The physician reported that on 23-JUN-2009, was seen in the physician's office with fatigue, left shoulder pain and a lump in her neck. The patient also had nausea but a good appetite. The physician believed there was lymph involvement. Blood tests were performed, complete blood cell count (CBC), streptococcal and a mononucleosis. The results test were normal. The patient was seen at the physician's office again (date unspecified), and patient's the lump was smaller, hard but still mobile. The patient also had a sore throat, stuffy nose, red eyes and shoulder pain. The shoulder had full range of movement but the patient had such pain with movement that she cried. It was noted that the lump on her neck was still visible. On 07-JUL-2007 the patient visited the physician's office and the physician reported that the shoulder pain, sore throat and fatigue had resolved. It was reported that the enlarged supraclavicular node was still palpable at about 1 cm, but non-tender. Follow up information has been received who reported that the 16 year old female with a rash allergy to amoxicillin, seasonal allergies and no adverse events following prior vaccination a who on 16-JUN-2009 was vaccinated IM with a first dose of GARDASIL in the left deltoid (lot number: 662300/0100Y) in the afternoon. Concomitant therapy included CONCERTA 36 mg, ZYRTEC, montelukast sodium (MSD). The patient was reported as a well child. On 23-JUN-2009, the patient developed left shoulder pain and a lump in left side of her neck (supraclavicular area) with 1 day of duration, tired, sore throat, stomach ache and headache. Physical was negative except for left supraventricular lymph node. On 30-JUN-2009 the patient developed sore throat, left shoulder pain, lump was sore and felt harder. She was tired, had malaise and she could not move her left arm. And left shoulder pops and hurts. She was treated with naproxen. It was reported that on 07-JUL-2009 the lump was smaller in size and did not hurt any more. On 10-AUG-2009 the lymph node was small but still palpable. On unspecified dates the following laboratory tests were performed : two rapid streptococcal, serum antinuclear antibodies test and mononucleosis test and lyme disease test all with negative results. Complete blood cell count (CBC) was within normal limits at 8.6 (14.5/41.8), 247 erythrocyte sedimentation rate (ESR) (41), serum C-reactive protein test (CRP) low and complete metabolic panel (CMP) was within normal limits. Additional information is no expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Polycystic ovaries
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with sulfonamide allergy and allergic reaction to CECLOR family of drugs who in September 2007, was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On the same date, the patient felt like fainting 15 minutes after her second dose. She also missed the third dose. The consumer stated that her daughter was also diagnosed with polycystic ovary syndrome (PCOS) after received her second dose of GARDASIL. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Mass, Pain in extremity
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 23 year old female patient who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL (lot # 660391/0063X; expiration date on 19-OCT-2010). Concomitant therapy included PROTONIX and YASMIN. On 14-AUG-2008 the patient developed a 5 to 7 mm lump just below the injection site with obvious pain. It was reported that on 13-FEB-2009 received the third dose of GARDASIL with no adverse effects. The nurse stated that the patient only had adverse events with the first dose of GARDASIL. At the time of reporting the patient had recovered. Follow up information was received from a Registered Nurse (R.N) concerning a 23 year old female medical assistant with no known drug allergies/drug reactions who on 08-AUG-2008 was vaccinated with the first dose of GARDASIL (Lot # 660391/0063X) intramuscularly into her left deltoid. There was no illnesses at time of vaccination. It was reported that on 14-AUG-2008 the patient felt increased discomfort, a lump was felt near the injection site. The left upper arm was slightly lower than usual injection site. There was a 5mm - 7mm palpable area. On 25-AUG-2008, the patient had an office visit for evaluation. There were no laboratory diagnostic tests performed. There was local care. On an unspecified date the patient recovered. In October 2008 and in February 2009 the patient was vaccinated with the second and third doses of GARDASIL (lot numbers not reported) (respectively), there were no adverse reactions following these injections. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician told by an other physician that a patient on an unspecified date was vaccinated with a dose of GARDASIL and experienced syncope. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Erythema, Oedema peripheral, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 years old female with asthma and a history of pulmonary stenosis who on 09-JUL-2009 was vaccinated with the first dose of GARDASIL (lot # 662300/0100Y) in right arm. Concomitant therapy included hepatitis A virus vaccine (unspecified) (manufactured by GlaxoSmithKline) in left arm. Later on 09-JUL-2009 evening the patient developed paresthesia in her left thumb, and it was red and swollen. The ring finger of her right hand and toes on her right foot became red, swollen and itchy. She had no fever or rash. The patient had been seen in office for medical attention. At the time of the report, the patient had not recovered. Information has been received from a nurse practitioner concerning a 14 year old female patient with asthma and a history of pulmonary stenosis and no illness at time of the vaccination who on 09-JUL-2009 was vaccinated with the first dose of GARDASIL (lot # 662300/0100Y) in right arm. Concomitant vaccination administered on 09-JUL-2009 included hepatitis A virus vaccine (unspecified) (GlaxoSmithKline) (lot# AHAVB244AD) intramuscularly in left arm. On the night of 09-JUL-2009, the patient's right thumb became red, itchy and swollen. On 10-JUL-2009 the patient made an appointment to visit the doctor to be evaluated. The patient was found to have the left thumb edema and redness, the fourth finger of the left hand edema and redness, the fourth toes of the right foot edema and redness. The patient also developed paresthesia in her left thumb. There were no relevant diagnostic tests performed. At the time of the report, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with her 1st dose of GARDASIL "recently". Subsequently the patient experienced rash on her body with itching. The rash were small fluid filled vesicles. The patient had sought medical attention and visited the office. She was recovering at the time of report. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse concerning a female patient in her early twenties who was vaccinated intramuscular with her first 0.5 ml dose of GARDASIL. The patient became lightheaded and needed to lie down for 5 minutes after administration. The patient had gone several hours without eating prior to receiving GARDASIL. She has since received two more dose of GARDASIL without any problems. The patient has sought medical attention at office and had recovered (date unknown). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Contusion
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with no medical history or drugs allergies, who in January 2008, was vaccinated with a first dose of GARDASIL. The patient received the second dose of GARDASIL six months after the first one, and the third dose of GARDASIL six months after the second one. Concomitant therapy included montelukast sodium (MSD), 5 mg, once at bed time. The mother stated that her daughter has experienced bruising everywhere on her body. She was unaware of when the bruising started but when she wakes up in the morning she had bruising. The patient had a blood work done. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Metrorrhagia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with one doses of GARDASIL, date of dose unknown, lot # was not reported. The patient experienced breakthrough bleeding after getting GARDASIL. Unspecified medical attention had been sought. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 13 year old female patient who "a few months ago" was vaccinated with a dose of GARDASIL (Lot # was not reported). It was reported that "a few months ago" the patient  experienced syncope after receiving GARDASIL. The patient sought medical attention with the nurse. It was reported that on an unspecified date the patient had recovered. Follow-up information was received on 26-AUG-2009, from a nurse, who reported that this event occurred "a few years ago when GARDASIL first came out". The nurse did not know who the patient was or the doctor was. Subsequently, the patient had fully recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Mass
Clinical narrative: Information has been received from a 26 year old consumer concerning herself, with no pertinent medical history and no known drug allergies/drug reactions who on 15-DEC-2008 was vaccinated with the first dose of GARDASIL. There was no concomitant medication reported. It was reported that after third vaccine of GARDASIL, "a week later", she experienced a medium sized lump that had not gone away. It was also reported that she did experience some pain after injection but that had gone away. There were no laboratory diagnostic tests performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Information has been received from a Nurse Practitioner (N.P) concerning a 24 year old female patient who on 11-MAY-2009 was vaccinated with the first dose of GARDASIL intramuscularly into the left deltoid. It was reported that the patient had been experiencing intermittent arm pain since receiving her initial dose of GARDASIL. The pain came and went with no pattern. The pain was described as muscle pain and felt like the day she initially received the vaccine. It was reported that the patient had arm pain when given the GARDASIL on 11-MAY-2009. The last time the patient had pain in that arm was two weeks ago. It was reported that the patient said it could be weeks between episodes of pain. The outcome of the patient was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Limb injury, Syncope
Clinical narrative: Information has been received from a nurse concerning a 23 year old female who in May 2009, was vaccinated with the first dose of GARDASIL (0.5ml, IM). On 13-JUL-2009 the patient received the second dose of GARDASIL (0.5ml, IM, lot# 661953/1130X, site: deltoid). There was no concomitant medication. On 13-JUL-2009 the patient fainted in the office after receiving her second dose. The patient woke up right away and she was fine afterward. On 13-JUL-2009 the patient recovered. Follow-up information has been received from a registered nurse concerning a 23 year old female with no known drug allergies who on 13-JUL-2009 at 10:50, was vaccinated with the second dose of GARDASIL (0.5ml, IM, lot#662518/2287Y, previously reported as lot# 661953/1130X) in her right deltoid. On 13-JUL-2009 at 10:50, the patient fainted "stubbed toe". The patient revived immediately. The patient had blood pressure checks for 1/2 hour. The patient drove home. On 13-JUL-2009 the patient recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a dose of GARDASIL on an unspecified date. The patient fainted after receiving a dose of GARDASIL. The patient had sought unknown medical attention. At the time of report the patient's status was recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning an "about 16 year" old female who on 10-JUL-2009, around 4:00 pm was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number not reported). Later that same day, at around 8:30 PM, the patient called the office and reported that she felt tired and lightheaded. No lab diagnostic studies were performed. It was noted that the patient had no adverse experiences after the first and second doses of GARDASIL. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Hypoaesthesia, Hypoaesthesia facial, Paraesthesia, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a consumer for GARDASIL, a Pregnancy Registry product, concerning her daughter a 17 year old female with pulmonary stenosis, cardiac murmur (which were diagnosed when she was only six weeks old) and drug hypersensitivity to codeine who on 01-JUL-2009 was vaccinated with the first dose of GARDASIL (LOT# 661841/0653X). There was no concomitant medication. Subsequently the patient experienced numbness and tingling on her face and fingers. On an unspecified date, the patient sought an unknown medical attention. The patient was prescribed BENADRYL and the numbness and tingling disappeared. The patient's LMP was in May 2009, on approximately 10-JUL-2009 the patient discovered that she was "2 and a half months" pregnant after conducting a home urine pregnancy test. The patient outcome was also reported as recovering. No further information is available at the time of this report. Follow up information has been received which reported that in February 2010, the patient delivered a normal infant with no congenital anomaly. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Angioedema, Eyelid oedema, Pruritus generalised, Swelling face
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 14 year old female who on 10-JUL-2009 was vaccinated intramuscularly with the first dose of GARDASIL (LOT# 662404/0312Y). On 11-JUL-2009 the patient experienced rash, itching, angioedema around eyes, swelling of eyelids and swelling of her face. On 11-JUL-2009 the patient woke up with puffy lower eye lids and itching all over her body. The patient sought medical attention by phone call and the physician instructed her to take BENADRYL three times a day for one week. Subsequently, the patient recovered within a few days. No further information is available at the time of this report. Follow-up information has been received from a physician concerning the 14 year old female with no drug allergies and no pertinent medical history who on 10-JUL-2009 in the AM was vaccinated intramuscularly with the first dose of GARDASIL (LOT# 662404/0312Y). The patient had no illnesses at the time of vaccination. In the evening (previous reported was on 11-JUL-2009), the patient felt itchy, but no rash developed. The next day, on 11-JUL-2009, the patient's both low eyelids were swollen, face and eyes were pruritic. The patient had no fever, no rash and no difficulty breathing.  he patient's mom was advised to give BENADRYL, PO, three time daily (TID). On 11-JUL-2009 the patient had recovered. No further information was expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Nausea, Pain
Clinical narrative: Information has been received from a advanced registered nurse practitioner concerning a 16 years old female who on 01-JUL-2009 was vaccinated with the first dose of GARDASIL. On 06-JUL-2009 the patient developed swollen glands, was aching all over and nausea feeling for a few days. On 10-JUL-2009 the patient was feeling better. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a nurse concerning that the date of onset of symptoms was incorrect in the original report. The nurse told the representative originally the symptoms began on 06-JUL-2009, but after speaking with the father again determined the symptoms actually started the day of vaccination 01-JUL-2009. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL. Subsequently the patient experienced "knot at the injection site where the GARDASIL was given". It was unknown if the patient sought medical attention. The patient was recovered at the time of report. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Cervical dysplasia, Drug exposure during pregnancy, Laboratory test normal, Loop electrosurgical excision procedure
Clinical narrative: Information has been received from a registered nurse through the Merck pregnancy registry concerning an 21 year old female who on 06-MAY-2009 was vaccinated with the second dose of GARDASIL (lot # not reported). A urine pregnancy test was done on 06-MAY-2009 and was negative. The patient's LMP was on 15-APR-2009 and EDD 20-JAN-2010. Additional information has been received from a physician concerning a 21 year old female with a history of 1 pregnancy and 1 live birth and a history of loop electrosurgical excision procedure for a severe cervical intraepithelial neoplasia (CIN3) on 06-APR-2009, who on 04-MAR-2009 was vaccinated with the first dose of GARDASIL (Lot number 661952/1129X). On 15-APR-2009 the patient had her last menstrual period and on 06-MAY-2009 received her second dose of GARDASIL (Lot number 661953/1130X). On 26-JUN-2009, the patient underwent an ultrasound which revealed an 8 week old fetus. On 31-AUG-2009 a Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was done. It was reported to be within normal limits. On 14-SEP-2009 an anomaly screening was done which was also reported to be within normal limits. Follow up information has been received from a physician concerning a female patient with a history of abnormal PAP and quitting smoking in August 2009. On 29-JAN-2009 PAP smear test was performed which resulted in high grade squamous intraepithelial lesion (HGSIL). A LEEP procedure was done in April 2009. The plan was reported to do a follow up colposcopy after the patient received dose number 3 of GARDASIL. The plan was also to do cervical length checks. On 31-AUG-2009 "MSQS" was performed and was reported to be negative. On 01-FEB-2010 from 39 gestation weeks and three days the patient had a normal female baby with no congenital anomalies and no complications or abnormalities. Her weight 7 pounds and 7 ounces, length 20 inches, apgar score 8/9 and head circumference 35cm. The patient had no complications during pregnancy, there were no infections or illness during pregnancy and not complications during labor. During pregnancy the patient was taking (NATURE MADE PRENATAL VITAMINS FORMULA) once a day. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Ultrasound scan abnormal, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a registered nurse through the Merck pregnancy registry concerning an 21 year old female who on 06-MAY-2009 was vaccinated with the second dose of GARDASIL (lot # not reported). A urine pregnancy test was done on 06-MAY-2009 and was negative. The patient's LMP was on 15-APR-2009 and EDD 20-JAN-2010. Additional information has been received from a physician concerning a 21 year old female with a history of 1 pregnancy and 1 live birth and a history of loop electrosurgical excision procedure for a severe cervical intraepithelial neoplasia (CIN3) on 06-APR-2009, who on 04-MAR-2009 was vaccinated with the first dose of GARDASIL (Lot number 661952/1129X). On 15-APR-2009 the patient had her last menstrual period and on 06-MAY-2009 received her second dose of GARDASIL (Lot number 661953/1130X). On 26-JUN-2009, the patient underwent an ultrasound which revealed an 8 week old fetus. On 31-AUG-2009 a Maternal Serum Alpha-Fetoprotein Screening (MSAFP) was done. It was reported to be within normal limits. On 14-SEP-2009 an anomaly screening was done which was also reported to be within normal limits. Follow up information has been received from a physician concerning a female patient with a history of abnormal PAP and quitting smoking in August 2009. On 29-JAN-2009 PAP smear test was performed which resulted in high grade squamous intraepithelial lesion (HGSIL). A LEEP procedure was done in April 2009. The plan was reported to do a follow up colposcopy after the patient received dose number 3 of GARDASIL. The plan was also to do cervical length checks. On 31-AUG-2009 "MSQS" was performed and was reported to be negative. On 01-FEB-2010 from 39 gestation weeks and three days the patient had a normal female baby with no congenital anomalies and no complications or abnormalities. Her weight 7 pounds and 7 ounces, length 20 inches, apgar score 8/9 and head circumference 35cm. The patient had no complications during pregnancy, there were no infections or illness during pregnancy and not complications during labor. During pregnancy the patient was taking (NATURE MADE PRENATAL VITAMINS FORMULA) once a day. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. There was no concomitant medication or vaccine reported. It was reported that the patient fainted for about 45 seconds. She had no other events or issues. It was reported that no treatment was needed and the patient was recovering at the time of the report. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Headache, Laboratory test normal, Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no medical history and no prior pregnancies who on 22-MAY-2009 was vaccinated with the first dose of GARDASIL. On approximately 06-MAY-2009, the patient became pregnant, the patient was unsure of her LMP. On 24-JUN-2009, an ultrasound was performed for dating. The results showed the baby was 7 weeks and 6 days old, within normal limits. On 29-MAY-2009 the patient experienced headache and received MOTRIN 200mg daily for treatment. The LMP was on approximately 02-MAY-2009 and the estimated delivery date was on 04-FEB-2010. Follow-up information has been received from a physician via an Outcome Pregnancy Questionnaire. It was reported that the patient was vaccinated on 23-MAY-2009 (previously reported as 22-MAY-2009).  The patient was on therapy with prenatal vitamin since 29-JUN-2009 daily. On approximately 10-JUL-2009, the patient experienced Urinary tract infection (UTI) and vaginitis monilial. From 10-JUL-2009 to 18-JUL-2009, the patient was on therapy with MACROBID twice a day, for 7 days, for the treatment with UTI. On 10-JUL-2009, the patient was on therapy with TERAZOL, every night at bedtime for 7 days, for the treatment with vaginitis monilial. On 13-NOV-2009, the patient was vaccinated with a H1N1. It was reported that the patient had low risk for Down's syndrome, "occult 83" and Trisomy 18. The mom had a quad screen which was reported to be normal. On 26-JAN-2010, at 38 weeks of gestation, the patient delivered a normal male baby weighing 3093gram. The baby's birth length was 20 inches. The Apgar score is 9/9.The baby had no congenital anomalies or other complications/abnormalities. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal mycotic infection
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no medical history and no prior pregnancies who on 22-MAY-2009 was vaccinated with the first dose of GARDASIL. On approximately 06-MAY-2009, the patient became pregnant, the patient was unsure of her LMP. On 24-JUN-2009, an ultrasound was performed for dating. The results showed the baby was 7 weeks and 6 days old, within normal limits. On 29-MAY-2009 the patient experienced headache and received MOTRIN 200mg daily for treatment. The LMP was on approximately 02-MAY-2009 and the estimated delivery date was on 04-FEB-2010. Follow-up information has been received from a physician via an Outcome Pregnancy Questionnaire. It was reported that the patient was vaccinated on 23-MAY-2009 (previously reported as 22-MAY-2009).  The patient was on therapy with prenatal vitamin since 29-JUN-2009 daily. On approximately 10-JUL-2009, the patient experienced Urinary tract infection (UTI) and vaginitis monilial. From 10-JUL-2009 to 18-JUL-2009, the patient was on therapy with MACROBID twice a day, for 7 days, for the treatment with UTI. On 10-JUL-2009, the patient was on therapy with TERAZOL, every night at bedtime for 7 days, for the treatment with vaginitis monilial. On 13-NOV-2009, the patient was vaccinated with a H1N1. It was reported that the patient had low risk for Down's syndrome, "occult 83" and Trisomy 18. The mom had a quad screen which was reported to be normal. On 26-JAN-2010, at 38 weeks of gestation, the patient delivered a normal male baby weighing 3093gram. The baby's birth length was 20 inches. The Apgar score is 9/9.The baby had no congenital anomalies or other complications/abnormalities. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Head injury, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a consumer concerning her daughter (a 21 year old female) with no medical history who on 14-JUL-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. It was reported that the patient fainted and hit her head immediately after receiving the vaccine on 14-JUL-2009. The patient sought medical attention by visiting the physician's office. A CT scan of the head was scheduled for 14-JUL-2009. The patient recovered after observation and monitoring. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Head injury, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a consumer concerning her daughter (a 21 year old female) with no medical history who on 14-JUL-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. It was reported that the patient fainted and hit her head immediately after receiving the vaccine on 14-JUL-2009. The patient sought medical attention by visiting the physician's office. A CT scan of the head was scheduled for 14-JUL-2009. The patient recovered after observation and monitoring. No further information is available.