chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 year old female with allergy to codeine, who on 19-MAR-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL. Concomitantly, the patient was vaccinated with hepatitis A vaccine, MENACTRA and Tdap. On 19-MAY-2009, the patient was vaccinated intramuscularly with the second 0.5ml of GARDASIL. The physician reported that the patient experienced heart rate greater than 150. On 13-JUL-2010, the patient was vaccinated intramuscularly with the third 0.5ml of GARDASIL. The patient experienced uncontrollable shivering, nausea and vomited once. Two lot numbers were provided: Lot number # 666118/1539Y ad 661841/0653X, but it was not specified which one corresponds to each dose. Lot number # 666118/1539Y could corresponds first dose and 661841/0653X could be the second dose. At the time of the report, the patient was recovered (dates unknown). The patient sought medical attention and went to a ER. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Colonoscopy normal, Computerised tomogram normal, Decreased appetite, Diarrhoea
Clinical narrative: Information has been received from a consumer concerning his approximately 20 year old female daughter with no pertinent medical history, drug reactions or allergies who on 07-MAY-2008 was vaccinated with a third dose of GARDASIL (Lot# number unknown). The dates of the first and second doses were not known at the time of the report. There was no concomitant medication. The reporter stated that "about a year ago" in approximately 2009 her daughter began experiencing weakness, fatigue, decreased appetite, muscle tremors, lightheadedness, dizziness and diarrhea. She had had several test completed and the results had all been negative. The mother mentioned that her daughter was hit by a car "last year" in 2009 while walking across the street. She did not sustain any broken bones, but she did hit her head and was sore following the accident. "Within the past two weeks" on approximately 05-JUL-2010 the patient "got really sick again and lost 9 pounds". Colonoscopy, blood work, CT scan and ultrasound tests were performed and the results were all normal. 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 by the physician who stated that this patient did not receive a GARDASIL injection by this office. Additional information is not  expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Haematology test normal, Laboratory test normal, Tremor
Clinical narrative: Information has been received from a consumer concerning his approximately 20 year old female daughter with no pertinent medical history, drug reactions or allergies who on 07-MAY-2008 was vaccinated with a third dose of GARDASIL (Lot# number unknown). The dates of the first and second doses were not known at the time of the report. There was no concomitant medication. The reporter stated that "about a year ago" in approximately 2009 her daughter began experiencing weakness, fatigue, decreased appetite, muscle tremors, lightheadedness, dizziness and diarrhea. She had had several test completed and the results had all been negative. The mother mentioned that her daughter was hit by a car "last year" in 2009 while walking across the street. She did not sustain any broken bones, but she did hit her head and was sore following the accident. "Within the past two weeks" on approximately 05-JUL-2010 the patient "got really sick again and lost 9 pounds". Colonoscopy, blood work, CT scan and ultrasound tests were performed and the results were all normal. 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 by the physician who stated that this patient did not receive a GARDASIL injection by this office. Additional information is not  expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal, Weight decreased
Clinical narrative: Information has been received from a consumer concerning his approximately 20 year old female daughter with no pertinent medical history, drug reactions or allergies who on 07-MAY-2008 was vaccinated with a third dose of GARDASIL (Lot# number unknown). The dates of the first and second doses were not known at the time of the report. There was no concomitant medication. The reporter stated that "about a year ago" in approximately 2009 her daughter began experiencing weakness, fatigue, decreased appetite, muscle tremors, lightheadedness, dizziness and diarrhea. She had had several test completed and the results had all been negative. The mother mentioned that her daughter was hit by a car "last year" in 2009 while walking across the street. She did not sustain any broken bones, but she did hit her head and was sore following the accident. "Within the past two weeks" on approximately 05-JUL-2010 the patient "got really sick again and lost 9 pounds". Colonoscopy, blood work, CT scan and ultrasound tests were performed and the results were all normal. 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 by the physician who stated that this patient did not receive a GARDASIL injection by this office. Additional information is not  expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient who on unspecified date was vaccinated with the first dose of GARDASIL. It was reported that the patient had flu like symptoms a few days after receiving her first dose of GARDASIL. The symptoms lasted 6 weeks and the patient is now recovered. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot #: not reported) (dose in the series unspecified). Subsequently the patient got pale and light-headed in the office when she received the GARDASIL injection. At the time of the report, the patient's paleness and light-headed improved. Patient sought unspecified medical attention. Follow up information has been received from the physician who reported that on 23-JUN-2010 the patient felt faint after receiving GARDASIL. It was resolved with in a few minutes. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot#: not reported). Subsequently the patient fainted after receiving the GARDASIL injection (no known which dose in the series). Patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a 15 year old patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot # and route not reported). The consumer stated that she was worried because almost everyone she knew had been having unspecified side effects but not her. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Colposcopy, Papilloma viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a female who "2-3 years ago' in approximately 2007 was vaccinated with the first dose of GARDASIL. Subsequently the patient had HPV that required several colposcopies. The nurse practitioner was not sure if the patient had HPV previous to vaccination. The nurse practitioner believed the patient might have gotten HPV from being sexually active. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on 09-DEC-2010 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 666949/0888Z), 0.5ml. Immediately after receiving the vaccine the patient turned pale and became dizzy. The physician had her relax in the office and gave her cookies and juice. No lab diagnostics studies were performed. The patient recovered before leaving the office. The patient has not followed up with the office with any other reactions. Follow up information has been received from the physician concerning the patient with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 09-DEC-2010 at almost 3:00 PM was vaccinated with the second dose of GARDASIL into the right arm. Shortly the physician found that the patient almost fainted and turned pale. Blood pressure was measured with the result of 74/64. She was remained after lying on the table and recovered few minutes after the vaccination. Repeat blood pressure was measured with the result of 95/67. Heart rate was 100. The patient did not have any adverse event following prior vaccination. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a now 19 year old female who in 2008 was vaccinated with the first dose of GARDASIL, IM. On 16-JUN-2010 the patient received the second dose (lot # 666118/1539Y), IM. On 16-JUN-2010, the patient experienced pain radiating "over the shoulder, to the elbow and finger tips" since the second dose was given, in addition, the patient experienced a rash, vomiting and fever. The patient did not have any reaction from the first dose, the patient went to urgent care center for medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a now 19 year old female who in 2008 was vaccinated with the first dose of GARDASIL, IM. On 16-JUN-2010 the patient received the second dose (lot # 666118/1539Y), IM. On 16-JUN-2010, the patient experienced pain radiating "over the shoulder, to the elbow and finger tips" since the second dose was given, in addition, the patient experienced a rash, vomiting and fever. The patient did not have any reaction from the first dose, the patient went to urgent care center for medical attention. At the time of the reporting, 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 concerning a female patient who on an unspecified date was vaccinated with "three doses" of GARDASIL (Lot# unknown), 0.5mL, IM. The physician reported that the patient was using GARDASIL and on an unspecified date experienced syncope. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU3, HEP, HPV4
Symptoms: Drug exposure during pregnancy, Premature delivery
Clinical narrative: Information has been received from a registered nurse, for the pregnancy registry for GARDASIL, concerning a 15 year old female patient with no pertinent medical history, drug reactions or allergies who on 07-AUG-2009 was vaccinated IM with a first dose of GARDASIL (Lot# unknown). On 13-OCT-2010, the patient was vaccinated IM with the third dose of GARDASIL (Lot# 666596/0766Z) (Expiration date: 15-Oct-2012). On 13-OCT-2010, the patient also received the third dose of RECOMBIVAX HB (Lot# unknown) (manufacturer unknown) and the first dose of AFLURIA (Lot# unknown) (manufacturer unknown). It was reported that the first dose of RECOMBIVAX HB (Lot# unknown) (manufacturer unknown) was administered on 02-MAR-2009. Patient's Last Menstrual Period (LMP) was 04-FEB-2010. The nurse reported that on 19-OCT-2010 at 36 weeks and 5 days from LMP, the patient delivered a baby boy. It was reported that the patient sought medical attention by a follow up visit. The baby experience has been captured in WAES# 1012USA02470B1. This is one of two reports from the same patient. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Anaemia, Blood glucose increased, Maternal exposure during pregnancy, Normal newborn
Clinical narrative: Information has been received from the Merck Pregnancy Registry, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with not pertinent medical history or drug reactions/allergies who on 15-SEP-2009 and 24-NOV-2009 was vaccinated with a first and a second dose of GARDASIL (Lot # not provided). There was no concomitant medication. On 23-MAR-2010, the patient received her third dose of GARDASIL (Lot # 662299/1099Y, expiration date on 17-APR-2010) and was 3 weeks and 3 days pregnant at that time. The last menstrual period was on 27-FEB-2010 and the estimated delivery date was on 04-DEC-2010. On 07-MAY-2010 a red blood cell count was performed and the result was 3.72 (slightly anemic). On 17-MAY-2010 a urinalysis was performed and the result was normal. No adverse event was reported. This was originally reported by a nurse. Follow up information has been received from the physician who confirmed that the patient received the third dose of GARDASIL on 23-MAR-2010 (Lot # 662299/1099Y). On 28-MAY-2010, an ultrasound was performed which confirmed the pregnancy, size and date (12.9 weeks of pregnancy on that date). On 24-JUN-2010, a Maternal Serum Alpha-Fetoprotein (MSAFP) was performed without any result available. It was also reported the patient's obstetric history. The patient had had one previous pregnancy and full term delivery at 38 weeks from LMP without birth defects. Follow up information has been received via a Pregnancy Questionnaire from an obstetrician who reported that the patient underwent an ultrasound on 28-MAY-2010 (which showed 12.9 weeks), 02-JUN-2010, at 13 week from LMP which was normal, on 07-JUL-2010 (which showed 20.5 weeks from LMP) and on 06-NOV-2010 at 32.4 weeks from LMP. On 27-SEP-2010, the patient was prescribed with ferrous sulfate 325 mg, QD for anemia until 03-MAR-2011. At 36 weeks from LMP, on 27-NOV-2010 the patient's group B streptococcus (GBS) was positive for and treated during labor. On 05-DEC-2010 at 40.2 weeks from LMP the patient delivered a normal male baby, and no other complications or abnormalities. The baby's weight was 6 pounds 12 oz and height was 19, apgar score results: 8/9 in with no congenital abnormalities. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell count decreased, Streptococcus test positive, Ultrasound antenatal screen normal, Urine analysis normal
Clinical narrative: Information has been received from the Merck Pregnancy Registry, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with not pertinent medical history or drug reactions/allergies who on 15-SEP-2009 and 24-NOV-2009 was vaccinated with a first and a second dose of GARDASIL (Lot # not provided). There was no concomitant medication. On 23-MAR-2010, the patient received her third dose of GARDASIL (Lot # 662299/1099Y, expiration date on 17-APR-2010) and was 3 weeks and 3 days pregnant at that time. The last menstrual period was on 27-FEB-2010 and the estimated delivery date was on 04-DEC-2010. On 07-MAY-2010 a red blood cell count was performed and the result was 3.72 (slightly anemic). On 17-MAY-2010 a urinalysis was performed and the result was normal. No adverse event was reported. This was originally reported by a nurse. Follow up information has been received from the physician who confirmed that the patient received the third dose of GARDASIL on 23-MAR-2010 (Lot # 662299/1099Y). On 28-MAY-2010, an ultrasound was performed which confirmed the pregnancy, size and date (12.9 weeks of pregnancy on that date). On 24-JUN-2010, a Maternal Serum Alpha-Fetoprotein (MSAFP) was performed without any result available. It was also reported the patient's obstetric history. The patient had had one previous pregnancy and full term delivery at 38 weeks from LMP without birth defects. Follow up information has been received via a Pregnancy Questionnaire from an obstetrician who reported that the patient underwent an ultrasound on 28-MAY-2010 (which showed 12.9 weeks), 02-JUN-2010, at 13 week from LMP which was normal, on 07-JUL-2010 (which showed 20.5 weeks from LMP) and on 06-NOV-2010 at 32.4 weeks from LMP. On 27-SEP-2010, the patient was prescribed with ferrous sulfate 325 mg, QD for anemia until 03-MAR-2011. At 36 weeks from LMP, on 27-NOV-2010 the patient's group B streptococcus (GBS) was positive for and treated during labor. On 05-DEC-2010 at 40.2 weeks from LMP the patient delivered a normal male baby, and no other complications or abnormalities. The baby's weight was 6 pounds 12 oz and height was 19, apgar score results: 8/9 in with no congenital abnormalities. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a nurse who heard from another healthcare professional about a male who this year, in 2010, was vaccinated with his first dose of GARDASIL. The nurse reported that the patient experienced fainted and tonic clonic movements immediately after vaccine administration in 2010. The outcome of the patient was not reported. No further information is available.
Sex: F
Vaccine: DTAP, HPV4, MNQ
Symptoms: Cold sweat, Fatigue, Limb discomfort
Clinical narrative: Information has been received from a Registered Nurse concerning a female patient who on 28-JUN-2010 was vaccinated with a dose of GARDASIL (Lot# unknown). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and MENACTRA. Nurse reported that the patient's mother called to the physician's office to say her daughter on 28-JUN-2010 was feeling tired, experienced discomfort in her arm and was cold and clammy. The patient sought medical attention by a Doctor's office visit. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Headache, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient with no pertinent medical history and no known drug reactions or allergies, who on 23-MAR-2010, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number 661954/0075Y) (Expiration date 15-MAR-2011). Concomitant therapy included FLONASE. On 26-MAY-2010, the patient received intramuscularly the second 0.5 mL dose of GARDASIL (lot number not specified). The physician reported that the patient experienced vomiting, dizziness, headache, fever and abdominal pain after receiving both doses of GARDASIL. The patient sought unspecified medical attention. No lab diagnostics studies were performed. The patient recovered after each dose (dates not provided). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient with no pertinent medical history and no known drug reactions or allergies, who on 23-MAR-2010, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number 661954/0075Y) (Expiration date 15-MAR-2011). Concomitant therapy included FLONASE. On 26-MAY-2010, the patient received intramuscularly the second 0.5 mL dose of GARDASIL (lot number not specified). The physician reported that the patient experienced vomiting, dizziness, headache, fever and abdominal pain after receiving both doses of GARDASIL. The patient sought unspecified medical attention. No lab diagnostics studies were performed. The patient recovered after each dose (dates not provided). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Breech presentation, Human chorionic gonadotropin positive, Laboratory test normal, Maternal exposure during pregnancy, Nephrolithiasis
Clinical narrative: Information has been received from a Registered Nurse (R.N.) for the pregnancy registry for GARDASIL concerning a 23 year old female patient with sulfonamide allergy and allergy to amoxicillin who on 17-MAR-2010 was vaccinated with the first dose of GARDASIL (Lot # 662529/1317Y) (expiration date: 10-MAY-2011) intramuscularly. There was no concomitant medication reported. It was reported that on 01-APR-2010, the patient received a pregnancy test in the office confirming that she was pregnant. The patient sought unspecified medical attention. The last menstrual period was in "February 2010" and the estimated delivery date was on 08-NOV-2010. No known adverse effect so far. Follow up information has been received from a physician concerning the female patient with no previous pregnancies and no concurrent medical conditions. On 13-MAY-2010, a Down's screen was performed for routine the result was normal. On 13-JUL-2010, an ultrasound was performed for routine and the result was normal. It was reported that on 20-NOV-2010 at 39 weeks from LMP, the patient delivered a male baby with 6 lbs 9 oz of weight and 19 inches in length with a head circumference of 13, Apgar score 9/9. The infant was normal. There were no congenital anomalies. During pregnancy the mother experienced kidney stone (date unknown). Additionally, the patient experienced breech in labor. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Normal newborn, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a Registered Nurse (R.N.) for the pregnancy registry for GARDASIL concerning a 23 year old female patient with sulfonamide allergy and allergy to amoxicillin who on 17-MAR-2010 was vaccinated with the first dose of GARDASIL (Lot # 662529/1317Y) (expiration date: 10-MAY-2011) intramuscularly. There was no concomitant medication reported. It was reported that on 01-APR-2010, the patient received a pregnancy test in the office confirming that she was pregnant. The patient sought unspecified medical attention. The last menstrual period was in "February 2010" and the estimated delivery date was on 08-NOV-2010. No known adverse effect so far. Follow up information has been received from a physician concerning the female patient with no previous pregnancies and no concurrent medical conditions. On 13-MAY-2010, a Down's screen was performed for routine the result was normal. On 13-JUL-2010, an ultrasound was performed for routine and the result was normal. It was reported that on 20-NOV-2010 at 39 weeks from LMP, the patient delivered a male baby with 6 lbs 9 oz of weight and 19 inches in length with a head circumference of 13, Apgar score 9/9. The infant was normal. There were no congenital anomalies. During pregnancy the mother experienced kidney stone (date unknown). Additionally, the patient experienced breech in labor. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from a nurse concerning a female patient with no pertinent medical history and no drug reactions/allergies who on an unspecified date was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. On an unspecified date, the patient experienced a rash at the injection site. There was no lab diagnostics studies performed. Unspecified medical attention was sought. On an unspecified date, the patient recovered from a rash at the injection site (that eventually cleared out). Follow-up information has been received from the nurse who confirmed that the female patient experienced a rash at the injection site. Additional information is not expected. Follow-up information has been received from the 26 year old female patient with penicillin allergy who on 24-JUN-2010 at 08:00 was vaccinated at upper left arm with the second dose of (previously was reported as first dose) GARDASIL (LOT# 0040Z). On 25-JUN-2010, the next day after shot, the patient stated she experienced reaction rash. The patient took BENADRYL and felt better. This is the first of two reports received from same source. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Human chorionic gonadotropin positive, Maternal exposure during pregnancy, Normal newborn
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female who on 02-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y). There were no any concomitant vaccinations at that time. In February 2010, the patient missed her appointment to receive the second dose of GARDASIL. On 05-APR-2010, the patient came to the physician's office for a Prenatal Care Visit. The patient reported her last menstrual period was 07-FEB-2010. On ultrasound the patient's pregnancy was confirmed. The patient was 13 weeks +4 days pregnant at the reporting time. The patient's estimated due date was 14-NOV-2010. Follow up information has been received from a completed questionnaire and the registered nurse concerning the female patient with cystic fibrosis carrier who experienced anemia during pregnancy. The patient was treated with Fe supplement. On 25-MAY-2010 maternal serum alpha-fetoprotein screening (MSAFP) was performed and the result was negative. On 21-NOV-2010, the patient delivered a normal female infant. There were no congenital anomalies. The infant experienced respiratory distress syndrome (RDS) which has been captured in WAES# 1005USA00540B1. Additional information has been received from the registered nurse concerning a female patient who 02-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y) intramuscularly into right deltoid. The patient had pregnancy test on 04-APR-2010 which was positive. The date of ultrasound was confirmed as 03-MAY-2010. This was the patient's first pregnancy. The patient did not seek medical attention. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female who on 02-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y). There were no any concomitant vaccinations at that time. In February 2010, the patient missed her appointment to receive the second dose of GARDASIL. On 05-APR-2010, the patient came to the physician's office for a Prenatal Care Visit. The patient reported her last menstrual period was 07-FEB-2010. On ultrasound the patient's pregnancy was confirmed. The patient was 13 weeks +4 days pregnant at the reporting time. The patient's estimated due date was 14-NOV-2010. Follow up information has been received from a completed questionnaire and the registered nurse concerning the female patient with cystic fibrosis carrier who experienced anemia during pregnancy. The patient was treated with Fe supplement. On 25-MAY-2010 maternal serum alpha-fetoprotein screening (MSAFP) was performed and the result was negative. On 21-NOV-2010, the patient delivered a normal female infant. There were no congenital anomalies. The infant experienced respiratory distress syndrome (RDS) which has been captured in WAES# 1005USA00540B1. Additional information has been received from the registered nurse concerning a female patient who 02-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y) intramuscularly into right deltoid. The patient had pregnancy test on 04-APR-2010 which was positive. The date of ultrasound was confirmed as 03-MAY-2010. This was the patient's first pregnancy. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Eye swelling, Lip swelling, Swelling face, Urticaria
Clinical narrative: Information has been received from a certified nurse midwife concerning a female patient who on an unspecified date was vaccinated IM with the second dose of GARDASIL and experienced swelling of the lips, face and eyes. In addition, the patient had broken out in hives. The patient sought unknown medical attention. Allergy testing was performed with unspecified result. Vaccine with GARDASIL was discontinued. At the time of report the patient's status was improved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Normal newborn
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female with cystic fibrosis carrier who on 02-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 683452/0671Y). On 21-NOV-2010, 41 weeks from LMP, the patient delivered a normal female infant with weight 3670, length 21, apgar score 7/9, head circumference 33.5. There were no congenital anomalies. On unspecified date, the infant experienced respiratory distress syndrome. At the time of the report, the outcome was unknown. The mother's experienced has been captured in WAES # 1005USA00540. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLUX(H1N1), HPV4
Symptoms: Alpha 1 foetoprotein normal, Maternal exposure during pregnancy, No adverse event, Normal newborn, Pre-eclampsia
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female who on 02-MAR-2010 was vaccinated with the first dose of GARDASIL when she was pregnant. The patient had not been given any other of GARDASIL. The patient was 20 weeks pregnant at the reporting time. The patient's LMP was approximately on 17-DEC-2009. EDD was on 23-SEP-2010. The patient sought medical attention. No adverse reactions reported. Follow up information has been received from the registered nurse concerning a 25 year old female who on 02-MAR-2010 was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y). Concomitant therapy on 02-MAR-2010 included a 0.5ml dose of H1N1. On 05-APR-2010, serum alpha-fetoprotein test (MSAFP) for screening was performed and the result was negative. On 22-APR-2010, ultrasound for dating and anatomy test was performed and the result was normal. The patient had 2 previous pregnancies and 2 full term deliveries with no pre-term deliveries, no spontaneous abortions, no elective terminations, no fetal deaths. There were no birth defect nor infant complications in previous pregnancies. The patient's LMP was 17-DEC-2009. EDD was 23-SEP-2010. At the time of the report, the outcome was unknown. Follow up information has been received from the nurse practitioner who reported that estimated conception date was 06-DEC-2009. The patient experienced proteinuria and preeclampsia during pregnancy. On 14-SEP-2010 the patient was vaccinated with a 0.5 ml dose of influenza virus vaccine (unspecified). On 14-SEP-2010 the patient delivered a female normal infant (weight 3600, length 19, apgar score 9/9, weeks from LMP 40 weeks 2 days, head circumference 35). There were no congenital anomalies. Other complications or abnormalities included: retained placenta, velamentous insertion site - placenta uneven villus maturity, thick chorionic plate. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLUX(H1N1), HPV4
Symptoms: Proteinuria, Retained placenta or membranes, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female who on 02-MAR-2010 was vaccinated with the first dose of GARDASIL when she was pregnant. The patient had not been given any other of GARDASIL. The patient was 20 weeks pregnant at the reporting time. The patient's LMP was approximately on 17-DEC-2009. EDD was on 23-SEP-2010. The patient sought medical attention. No adverse reactions reported. Follow up information has been received from the registered nurse concerning a 25 year old female who on 02-MAR-2010 was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y). Concomitant therapy on 02-MAR-2010 included a 0.5ml dose of H1N1. On 05-APR-2010, serum alpha-fetoprotein test (MSAFP) for screening was performed and the result was negative. On 22-APR-2010, ultrasound for dating and anatomy test was performed and the result was normal. The patient had 2 previous pregnancies and 2 full term deliveries with no pre-term deliveries, no spontaneous abortions, no elective terminations, no fetal deaths. There were no birth defect nor infant complications in previous pregnancies. The patient's LMP was 17-DEC-2009. EDD was 23-SEP-2010. At the time of the report, the outcome was unknown. Follow up information has been received from the nurse practitioner who reported that estimated conception date was 06-DEC-2009. The patient experienced proteinuria and preeclampsia during pregnancy. On 14-SEP-2010 the patient was vaccinated with a 0.5 ml dose of influenza virus vaccine (unspecified). On 14-SEP-2010 the patient delivered a female normal infant (weight 3600, length 19, apgar score 9/9, weeks from LMP 40 weeks 2 days, head circumference 35). There were no congenital anomalies. Other complications or abnormalities included: retained placenta, velamentous insertion site - placenta uneven villus maturity, thick chorionic plate. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hypoaesthesia, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female with no medical history and drug allergies who on 29-SEP-2010 was vaccinated 0.5 ml IM with the first dose of GARDASIL (lot # 663559/1178Y, expiration date unknown). There was no concomitant therapy. The patient experienced swelling on an unspecified date. The patient did not contact the office when the swelling occurred, the medical assistant was made aware of this reaction today, 08-DEC-2010 when the patient received the second dose of GARDASIL. The patient received the second dose of GARDASIL (lot # 1017Z, expiration date 12-APR-2013) 0.5 ml IM right arm and had an immediate reaction of redness and swelling. The patient while still in office experienced dizziness along with numbness and tingling that went down into her right hand. The patient was treated with BENADRYL and warm compress. She did not recover at the time of report. No lab diagnostic studies performed. In follow-up, the medical assistant indicated that the 14 year old female who on 08-DEC-2010, 9:15AM was vaccinated IM into left deltoid with the second dose of GARDASIL (lot # 663559/1178Y). Concomitant therapy included the first dose of FLUZONE (lot # U3580AA) vaccinated IM into left deltoid on 08-DEC-2010, 9:15AM. On 08-DEC-2010, 9:15AM the patient experienced immediate swelling with injection site and redness. The patient complained of dizziness and headache, as well as numbness and tingling in her left hand. She was monitored for an hour and a half. Symptoms improved and the patient had recovered. No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site swelling, Paraesthesia, Swelling
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female with no medical history and drug allergies who on 29-SEP-2010 was vaccinated 0.5 ml IM with the first dose of GARDASIL (lot # 663559/1178Y, expiration date unknown). There was no concomitant therapy. The patient experienced swelling on an unspecified date. The patient did not contact the office when the swelling occurred, the medical assistant was made aware of this reaction today, 08-DEC-2010 when the patient received the second dose of GARDASIL. The patient received the second dose of GARDASIL (lot # 1017Z, expiration date 12-APR-2013) 0.5 ml IM right arm and had an immediate reaction of redness and swelling. The patient while still in office experienced dizziness along with numbness and tingling that went down into her right hand. The patient was treated with BENADRYL and warm compress. She did not recover at the time of report. No lab diagnostic studies performed. In follow-up, the medical assistant indicated that the 14 year old female who on 08-DEC-2010, 9:15AM was vaccinated IM into left deltoid with the second dose of GARDASIL (lot # 663559/1178Y). Concomitant therapy included the first dose of FLUZONE (lot # U3580AA) vaccinated IM into left deltoid on 08-DEC-2010, 9:15AM. On 08-DEC-2010, 9:15AM the patient experienced immediate swelling with injection site and redness. The patient complained of dizziness and headache, as well as numbness and tingling in her left hand. She was monitored for an hour and a half. Symptoms improved and the patient had recovered. No further information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, No adverse event, Normal newborn, Traumatic delivery, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a female patient who in September 2009, was vaccinated with the first dose of GARDASIL. In November 2009, the patient received her second dose of GARDASIL. It was reported that the patient went to the physician's office and was told she is pregnant and is due 01-DEC-2010. The patient sought unspecified medical attention. The physician reported that the patient will receive the third dose of GARDASIL after the pregnancy. The last menstrual period was on 24-FEB-2010. No adverse event involved. Follow up information received from a physician indicated that the patient was a 26 year old female with a previous full term pregnancy; mild depression, anxiety and a medical history seizure (last in 2004). Concomitant therapy included prenatal vitamins. On 27-APR-2010 at 8 weeks of pregnancy, she had an ultrasound for dates. The patient declined the amniocentesis and the MSAFP. Follow up information has been received from a licensed practical nurse concerning the female patient with no infections or illnesses during pregnancy and with no concurrent medical condition or family history. The nurse reported that on 24-NOV-2010 at 39 weeks from LMP, the patient delivered a male baby with 8 pounds and 14 ounces of weight and 21 inches of length, apgar score 8/9. The infant was normal. There were no congenital anomalies. There were no other complications or abnormalities. There were no complications during pregnancy. During labor the patient experienced secondary laceration perineum. No diagnostic test was performed during pregnancy. At the time of the report, the patient's outcome from secondary laceration perineum was unknown. Follow up information has been received from the physician indicating that the patient delivered laceration was not due to vaccine. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Maternal exposure during pregnancy, Nausea, No adverse event, Normal newborn
Clinical narrative: Information has been received from Merck Pregnancy Registry for GARDASIL from a physician's office worker concerning a 14 year old female with no pertinent medical history reported and no drug reactions or allergies reported who on 19-APR-2010 was vaccinated with a first dose of GARDASIL (lot # 659180/1758U) 0.5mL. There was no concomitant medication. Later was found out that she was pregnant at the time she was given the vaccine. She had "9 weeks and 4 days" of pregnant gestation. Her last menstrual period was on approximately on 02-APR-2010 and estimate delivery date is on approximately on 07-JAN-2011. No adverse event was reported. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. Follow up information has been received from a licensed practical nurse via a complete pregnancy questionnaire and telephone call, concerning the 14 year old female patient with asthma, allergic rhinitis, and causalgia of upper limbs and a history of having had a spontaneous abortion or miscarriage (date unspecified) and one previous pregnancy resulting in a full term delivery without birth defects and no complications during pregnancy (date unspecified). Concomitant medications used in this pregnancy included cetirizine hydrochloride, KEFLEX and prenatal vitamins (unspecified). It was confirm that date of last menstrual period was on 02-APR-2011 and estimate delivery date was on 07-JAN-2011. The nurse reported that the estimated conception date was on 15-APR-2010. On approximately in June 2010, the patient experienced vomiting and nausea and was treated with 12.5mg twice a day with promethazine. Prenatal laboratory tests included two ultrasound performed on 08-JUN-2010 and on 26-AUG-2010 for evaluating the fetus size and position. Other diagnostic laboratory tests performed included a Gestational Blood Sugar (GBS) performed on 30-NOV-2010 (Also reported as 30-NOV-2011). On 29-DEC-2010, the patient delivered a normal, healthy male baby at 39 weeks from LMP without congenital anomalies or other complications, who weighted 6lb 11 oz, 19 cm length, APGAR score 7/9 and a head circumference 33 (units not provided). It was reported that the patient did not have complications during pregnancy or during labor/delivery, and no illnesses during pregnancy. At the time of the report the outcome for nausea and vomiting was not reported. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound antenatal screen normal, Vomiting
Clinical narrative: Information has been received from Merck Pregnancy Registry for GARDASIL from a physician's office worker concerning a 14 year old female with no pertinent medical history reported and no drug reactions or allergies reported who on 19-APR-2010 was vaccinated with a first dose of GARDASIL (lot # 659180/1758U) 0.5mL. There was no concomitant medication. Later was found out that she was pregnant at the time she was given the vaccine. She had "9 weeks and 4 days" of pregnant gestation. Her last menstrual period was on approximately on 02-APR-2010 and estimate delivery date is on approximately on 07-JAN-2011. No adverse event was reported. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. Follow up information has been received from a licensed practical nurse via a complete pregnancy questionnaire and telephone call, concerning the 14 year old female patient with asthma, allergic rhinitis, and causalgia of upper limbs and a history of having had a spontaneous abortion or miscarriage (date unspecified) and one previous pregnancy resulting in a full term delivery without birth defects and no complications during pregnancy (date unspecified). Concomitant medications used in this pregnancy included cetirizine hydrochloride, KEFLEX and prenatal vitamins (unspecified). It was confirm that date of last menstrual period was on 02-APR-2011 and estimate delivery date was on 07-JAN-2011. The nurse reported that the estimated conception date was on 15-APR-2010. On approximately in June 2010, the patient experienced vomiting and nausea and was treated with 12.5mg twice a day with promethazine. Prenatal laboratory tests included two ultrasound performed on 08-JUN-2010 and on 26-AUG-2010 for evaluating the fetus size and position. Other diagnostic laboratory tests performed included a Gestational Blood Sugar (GBS) performed on 30-NOV-2010 (Also reported as 30-NOV-2011). On 29-DEC-2010, the patient delivered a normal, healthy male baby at 39 weeks from LMP without congenital anomalies or other complications, who weighted 6lb 11 oz, 19 cm length, APGAR score 7/9 and a head circumference 33 (units not provided). It was reported that the patient did not have complications during pregnancy or during labor/delivery, and no illnesses during pregnancy. At the time of the report the outcome for nausea and vomiting was not reported. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Mobility decreased, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with a history of obsessive-compulsive disorder and premenstrual tension and no allergies who was vaccinated intramuscularly with three 0.5ml doses of GARDASIL (respective lot#s are 665547/1318Y, 662304/1013Y and 662299/1099Y also reported as "099Y") respectively on 24-NOV-2009, 20-APR-2010 and 09-JUN-2010. Concomitant therapy included LEXAPRO and ZOVIA. On 09-JUN-2010, after receiving the third dose, the patient remained in the office for 20 minutes. When checked she complained of numbness and tingling throughout her body, and it was hard for her to move. She was seen by doctor, observed and rested in the office for 25 minutes and then felt better. She then left the office. At the time of this report, the patient had recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular, Vaginal discharge
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who on an unknown date was vaccinated with the first and second dose of GARDASIL. On 18-MAY-2010, the patient was vaccinated with the third dose of GARDASIL. The physician reported that after the patient received the first and second dose of GARDASIL, she started to have vaginal discharge. Then, after the patient received the third dose of GARDASIL, she started to have an irregular period. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Vaccination site pain
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with type 1 diabetes and no known drug reactions or allergies, who on 01-JUN-2010, was vaccinated with the first 0.5 mL dose of GARDASIL (route not provided) (lot number 661952/1129X). Concomitant therapy included HUMALOG. In June 2010, "recently", the patient experienced a dime sized painful swelling and redness at the injection site. It was also hard to the touch. The patient called the physician. No lab diagnostics studies were performed. At the time of reporting the patient had not recovered. Follow up information has been received from the consumer concerning her 11 year old daughter with type 1 diabetes mellitus, no known drug allergies, no illness at time of vaccination, who on 01-JUN-2010 was vaccinated with a first dose of GARDASIL (Lot # 661952/1129X) in her left deltoid at 10:15. The patient experienced swelling at the injection site, painful at site, redness and hard to touch at the injection site. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.