chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: RV5
Symptoms: Headache
Clinical narrative: Information has been received from a certified medical assistant concerning a 33 year old female nurse with drug hypersensitivity to DEMEROL and a flounder allergy who on 04-DEC-2007 administered a dose of Rotateq (lot# 657048/0909U) to an infant that spit the vaccine into the nurse's left eye.  The eye was immediately flushed with water but still irritated, stinging, itchy and felt like something was in it.  The nurse also experienced headache and she washed her face with alcohol.  The nurse sought medical attention in the physician's office.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested. 02/11/2010 Follow-up information from the reporting certified medical assistant indicated that upon administration to an infant (WAES# 0801USA0063) the 33 year old female nurse got a "spray" of ROTATEQ (lot# 657048/0909U) in her face and into her eyes (not sure how much). The patient experienced some irritation in the eye and stinging but was "fine after an hour or so." Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5, UNK
Symptoms: Crying, Similar reaction on previous exposure to drug, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning an infant male who in approximately 2007 was vaccinated with his first dose of Rotateq.  Concomitant vaccinations administered during the same visit for the initial dose included other unspecified vaccinations.  On that same day the patient experienced vomiting of his initial dose.  Subsequently, the patient recovered.  On 03-DEC-2007 the 6 month old male was vaccinated with his third dose of Rotateq.  Concomitant vaccinations included other vaccinations described as "shots."  On that same day, the patient experienced vomiting within 5 minutes of the third dose and crying.  It was not specified if the vomiting was before or after the child began crying but the Rotateq was administered first (prior to the "injection" vaccines).  It was noted that the patient received the second dose alone and was tolerated.  The patient was seen by the physician immediately after vomiting.  The outcome was unknown.  There was no product quality complaint.  No further information is available.
Age: 0.5
Sex: U
Vaccine: MMR, PNC, RV5, VARCEL
Symptoms: Viral rash, Wrong drug administered
Clinical narrative: Information has been received from a physician and an office manager concerning a 6 month old patient who on approximately 29-OCT-2007 was vaccinated PO with a fourth dose of Rotateq (no lot number was provided) in place of PREVNAR.  Concomitant vaccinations administered on that same day included a dose of Varivax (MSD), MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (MSD) and a dose of of FLUZONE.  Subsequently the patient developed a viral rash which had since resolved.  It was unknown whether medical attention was sought.  It was noted that the patient had already received Rotateq at 2 months, 4 months and 6 months.  There was no product quality complaint.  Additional information has been requested. 02/11/2010 Follow-up information has been received from a physician concerning a 12 month old male with no pre-existing conditions or drug allergies who on 29-OCT-2007 at 14:00 was vaccinated PO with a fourth dose of GARDASIL (lot# 09024). There was no illness at the time of vaccination. Concomitant vaccinations administered that same day at 14:00 included the first SC does of VARIVAX (lot# 659159/1369U) in the left thigh, the first SC dose of MMR II (lot# 657344/0527U) in the left thigh, the fourth IM dose PREVENAR (lot# 370143D) in the right thigh. No labs or dianostic studies were performed. Subsequently the patient recovered.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who on 06-DEC-2007 was vaccinated with a dose of Rotateq.  The patient did not experience any known symptoms.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool positive, Diarrhoea, Gastroenteritis, Laboratory test, Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old male with no pertinent medical history or drug allergies who on 20-NOV-2007 was vaccinated PO with a single dose of Rotateq (lot# 656659/0942U).  Concomitant vaccinations administered on that same day included a dose of PedvaxHIB (OMPC) (MSD), a dose of PEDIARIX and a dose of PREVNAR.  On 22-NOV-2007 the patient experienced vomiting and diarrhea.  On 23-NOV-2007 the patient was examined in the emergency room the day after symptoms started and was released that same day.  Laboratory diagnostic studies included unspecified tests.  The patient's stool also tested positive for rotavirus.  The patient also contacted the physician's office for medical attention.  Subsequently, the patient recovered. There was no product quality complaint.  It was also noted that on 24-NOV-2007 the patient's parents experienced gastrointestinal symptoms (unspecified) which lasted 48 hours then resolved (WAES# 0712USA04831).
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 9 week old male with no pertinent medical history or drug allergies who on 20-NOV-2007 was vaccinated PO with a single dose of Rotateq (lot# 656659/0942U).  Concomitant vaccinations administered on that same day included a dose of PedvaxHIB (OMPC) (MSD), a dose of PEDIARIX and a dose of PREVNAR.  On 22-NOV-2007 the patient experienced vomiting and diarrhea.  On 23-NOV-2007 the patient was examined in the emergency room the day after symptoms started and was released that same day.  Laboratory diagnostic studies included unspecified tests.  The patient's stool also tested positive for rotavirus.  The patient also contacted the physician's office for medical attention.  Subsequently, the patient recovered. There was no product quality complaint.  It was also noted that on 24-NOV-2007 the patient's parents experienced gastrointestinal symptoms (unspecified) which lasted 48 hours then resolved (WAES# 0712USA04831).
Sex: U
Vaccine: RV5
Symptoms: Gastrointestinal disorder, Secondary transmission
Clinical narrative: Information has been received from a registered nurse concerning adult patients who were recently exposed to their child (WAES # 0712USA02913) who was vaccinated with a dose of Rotateq (lot# 656659/0942U) on 20-NOV-2007.  Subsequently the patients experienced gastrointestinal symptoms (unspecified) one day after the patient was examined in the emergency room on 24-NOV-2007.  The parents' symptoms lasted 48 hours and then resolved.  This is one of several reports from the same source.  Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Accidental exposure, Infantile spitting up
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated with a dose of ROTATEQ. Subsequently the patient spit up the dose which then splashed into his eye. No adverse events were reported. The patient's eye was rinsed with water by the nurse in the office and the physisican was also spoken to for medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008. Follow-up information has been received from a health professional concerning a 17 week old, male with no pre-existing medical conditions or allergies who on 13-DEC-2007 at 11:00 was vaccinated PO with his second dose of ROTATEQ (lot# 657670/1108U). There was no illness at the time of vaccination. Concomitant vaccinations administered on the same day at 11:00 included the second IM dose of IPOL (lot# 1069) in the right thigh, the second IM dose of ACTHIB (lot# UF207AP) in the right thigh and the second IM dose of DAPTACEL (lot# C2749BA) in the left thigh. Upon administration of ROTATEQ (lot# 657670/1108U), the baby was resisting and arched his back while also spitting the vaccine out, spilling onto his face and into his right eye. The eye was washed several times with normal saline. No symptoms developed therefore no treatment was needed. On that same day the patient recovered. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a physician concerning a 19-week-old female with no medical history who on 09-AUG-2007 was vaccinated PO with the first dose of Rotateq.  On the morning of 11-OCT-2007, the patient was vaccinated PO with second dose of Rotateq (Lot #656838/0968U).  Concomitant vaccinations administered in the morning of 11-OCT-2007 included the second IM dose of Daptacel (Lot #C2657AA), the second IM dose of Comvax (OMPC) (MSD) (Lot #657180/0224U) and the second IM dose of PREVNAR (Lot #C45888).  There was no illness at the time of vaccination.  The physician reported that on 12-OCT-2007, the patient developed meconium-like stool and diarrhea.  The stool was not tested and no other laboratory/diagnostic tests were performed.  On 14-OCT-2007, 36 hours after onset, the patient's black meconium-like stool and diarrhea resolved.  No further information is available.
Age: 0.2
Sex: F
Vaccine: RV5, UNK
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a registered nurse concerning an approximately 56 day old female with no pertinent medical history and no drug reactions/allergies, who on 07-DEC-2007 was vaccinated po with a "first dose of series" ROTATEQ (lot number: 657514/0667U). Concomitant therapy included: 'routine two month old vaccines". On 07-DEC-07 the patient had two liquid black stools. No further information was provided regarding this adverse experience. No lab diagnostic studies were performed. The outcome was reported as recovered on 08-DEC-07. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Rash erythematous, Rash generalised, Rash papular, Viral rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9-week-old female birth twin with no medical history or allergies who on 14-DEC-2007 was vaccinated PO with the first 2.0 mL dose of ROTATEQ (Lot #657663/1461U). There was no concomitant therapy. The physician reported that on 15-DEC-2007, the patient was seen in his office due to a generalized red papular, viral-type rash that she had from head to toe including her palms and soles. The physician stated that the rash appeared to be a viral-type rash. The physician also reported that the patient had increased spitting. The physician noted that the patient did not have diarrhea, blood in the stool or fever. There were no lesions in the oral cavity, no petechiae, purpura, blisters, pustules or vesicles associated with the rash. No laboratory/diagnostic tests were performed. The physician noted that the patient's identical twin sister received ROTATEQ and was okay. He also reported that a school-aged brother was okay and that no other family member had symptoms. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 week old patient who on 19-Dec-2007 was vaccinated with the first dose of Rotateq by mistake.  No medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial and follow-up information has been received concerning a few patients who were vaccinated with their first doses of Rotateq after 12 weeks of age.  No adverse experience related to this event.  There was no product quality complaint.  Attempts made to obtain identifying information to distinguish the individuals mentioned in this report were unsuccessful. . This is in follow-up to report (s) previously submitted on 1/15/2008.  Follow-up information indicated that the physician was not sure who the patients were, but additional information is expected. No additional information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old black female with allergies to guaifenesin (ROBITUSSIN) and doxycycline who on 20-Mar-2007 was vaccinated IM, into the right deltoid, with a first dose of Gardasil (lot #654702/0011U).  On 20-Mar-2007, the patient experienced pain at the injection site.  The pain lasted for 1 week and then on 27-Mar-2007, the patient resolved without treatment.  On 16-Aug-2007 the patient was vaccinated IM, into the right deltoid with a second dose of Gardasil.  On 16-Aug-2007, the patient developed a sore muscle and arm at and around the site of injection.  On 23-Aug-2007, the patient recovered.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Diagnostic procedure, Drug exposure during pregnancy, Premature baby, Premature labour, Ultrasound scan
Clinical narrative: Information has been received from an other health professional from the pregnancy registry concerning a 19 year old female patient with an amoxicillin allergy and no pertinent medical history who on 09-Feb-2007, was vaccinated with a 0.5ml dose of Gardasil (lot #655619/1427F).  There was no concomitant medication.  It was reported that the patient was pregnant when she received the vaccine.  Unspecified medical attention was sought.  The patient's last menstrual period was reported to be 14-Jan-2007 and her estimated date of delivery was 21-Oct-2007.  Method of pregnancy confirmation was not reported.  Follow-up information received from the Pregnancy registry indicated that the patient was a smoker.  It was reported that she had pre-term labor, and delivered the baby at 33 weeks on 07-Sep-2007.  The infant was a male weighing 5 lbs and 20 oz.  There were no congenital anomalies.  The baby was in RICN for 2 weeks and had an apnea monitor.  Medications used during this pregnancy for pre-term labor were Brethinc injection and bethamethasone 12 mg intramuscularly on 05-Sep-2007.  Laboratory diagnostic tests included an ultrasound on 07-Jun-2007 which was within normal limits and examination of cervical length on 18-Jul-2007.  On 14-Aug-2007 a diagnostic test for fetal fibronectin was performed.  On 05-Sep-2007, an ultrasound was performed for the preterm labor.  On 27-Dec-2007, a follow up phone call was made and it was reported that the infant is doing well and no longer required the apnea monitor.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Ultrasound abdomen normal
Clinical narrative: Information has been received from a healthcare worker concerning a 24 year old female with a history of previous pregnancy and elective termination and no know drug allergies who on 05-FEB-2007 was vaccinated with a 0.5 mL first dose of Gardasil (Lot # 654741/0013U) while being pregnant. Concomitant therapy included PRIMACARE ONE during pregnancy. The patient's last menstrual period was 16-JAN-2007 and her estimated date of delivery is 23-OCT-2007. There were no adverse events. The patient sought unspecified medical treatment. On 01-MAR-2007, an ultrasound was performed which showed a normal fetal heart rate. No product quality complaint was involved. On 26-OCT-2007 (40 weeks 3 days from LMP), the patient gave birth to a 8 lb 8 oz normal, male infant with no congenital anomalies. However, it was noted that during labor/delivery the baby had shoulder dystocia and was born with a clavicle fracture. There were no complications or illnesses/infections during pregnancy. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Candidiasis, Cervix disorder, Drug exposure during pregnancy, Gastrooesophageal reflux disease, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician through the Pregnancy Registry concerning a 30 year old white female with no medical history or allergies who on 21-MAR-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (lot# 657006/0188U).  Concomitant therapy included prenatal vitamins.  On 21-MAR-2007, the patient was inadvertently administered the vaccine.  It was reported that the patient's last menstrual period was (LMP) 21-JAN-2007.  A urine pregnancy test and an ultrasound was performed.  The patient was reported to be 8 weeks and 3 days pregnant.  Her reported estimated delivery date was 28-OCT-2007.  The result of the ultrasound was normal.  On 19-APR2007, an ultrasound was performed to screen for chromosomal abnormalities.  It was reported to be normal.  On 21-MAY-2007 and 06-JUN-2007 both ultrasounds were also reported as normal.  On 31-AUG-2007, the patient was prescribed Nystatin (topical) twice a day for the treatment of candida.  On 05-OCT2007, the patient was prescribed VISTARIL 25mg PRN for the treatment of insomnia.  On 19-OCT-2007, an ultrasound was performed and the results were reported to be small for dates but normal.  On an unknown date in 2007 the patient was prescribed ZANTAC 150mg twice a day for the treatment of gastrooesophageal reflux disease (GERD).  There were no previous pregnancies, no spontaneous abortions (miscarriages) and no live births reported.  On 06-NOV-2007, the patient gave birth to a live born infant weighing 4175 grams and 19 3/4 inches.  She was 41 weeks from her LMP.  The infant was reported to be normal and there were no congenital anomalies.  There were no complications during the pregnancy or labor and delivery except, it was reported that the patient had failure to dilate.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia, Laboratory test normal, Pregnancy test urine positive, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician through the Pregnancy Registry concerning a 30 year old white female with no medical history or allergies who on 21-MAR-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (lot# 657006/0188U).  Concomitant therapy included prenatal vitamins.  On 21-MAR-2007, the patient was inadvertently administered the vaccine.  It was reported that the patient's last menstrual period was (LMP) 21-JAN-2007.  A urine pregnancy test and an ultrasound was performed.  The patient was reported to be 8 weeks and 3 days pregnant.  Her reported estimated delivery date was 28-OCT-2007.  The result of the ultrasound was normal.  On 19-APR2007, an ultrasound was performed to screen for chromosomal abnormalities.  It was reported to be normal.  On 21-MAY-2007 and 06-JUN-2007 both ultrasounds were also reported as normal.  On 31-AUG-2007, the patient was prescribed Nystatin (topical) twice a day for the treatment of candida.  On 05-OCT2007, the patient was prescribed VISTARIL 25mg PRN for the treatment of insomnia.  On 19-OCT-2007, an ultrasound was performed and the results were reported to be small for dates but normal.  On an unknown date in 2007 the patient was prescribed ZANTAC 150mg twice a day for the treatment of gastrooesophageal reflux disease (GERD).  There were no previous pregnancies, no spontaneous abortions (miscarriages) and no live births reported.  On 06-NOV-2007, the patient gave birth to a live born infant weighing 4175 grams and 19 3/4 inches.  She was 41 weeks from her LMP.  The infant was reported to be normal and there were no congenital anomalies.  There were no complications during the pregnancy or labor and delivery except, it was reported that the patient had failure to dilate.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemoglobin decreased, Pregnancy test positive, Urinary tract infection
Clinical narrative: Initial and follow up information has been received as part of a pregnancy registry, from a physician, concerning a 19 year old caucasian female patient with migraine headaches and cervical dysplasia, and no known drug allergies, who on 23-Aug-2006 was vaccinated with the first dose of Gardasil (Lot #653650/0702F), and on Oct-2006 was vaccinated with the second dose of Gardasil (Lot #653735/0688F).  The physician reported that since she received her second dose, she has become pregnant; confirmed by a pregnancy test which was positive.  The date of the LMP was 01-FEB-2007, estimated date of conception on 15-FEB-2007, with an estimated date of delivery on 08-NOV-2007.  She has not received the third dose.  Pregnancy is normal to date (no adverse event).  Prenatal vitamins (manufacturer unspecified), 1 tablet daily, were initiated on 21-MAR-2007.  Follow up information from the physician indicated that on 18-May-2007, the patient had an "uncomplicated urinary tract infection;" treatment included nitrofurantoin (MACROBID).  Routine prenatal labs were within normal limits, and on 26-AUG-2007, the patient's hemoglobin was 11.9 (units not specified).  There were no complications during pregnancy.  On 24-AUG-2007, ferrous sulfate (SLOW FE) was initiated.  On 30-OCT-2007, at 38.5 weeks of gestation, the patient vaginally delivered a normal caucasian male infant, with a birth weight of 3825 grams and an Apgar score of 8/9.  There were no complications or abnormalities.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Delivery, Drug exposure during pregnancy, Full blood count, HIV test
Clinical narrative: Information has been received from a registered nurse through the Merck Pregnancy registry concerning an 18 year old white female with asthma and a penicillin allergy with a history of 0 pregnancies and 0 live births who on 29-NOV-2006 was vaccinated with a dose of Gardasil (Lot 654540/0800F).  On 13-FEB-2007, an HCG level was performed and was negative.  On 14-FEB-2007, she received her second vaccination (Lot 655619/1427F).  Concomitant therapy included albuterol.  On approximately 14-MAR-2007 the patient became pregnant (LMP 23-FEB-2007).  Laboratory diagnostic studies performed included CBC, prenatal antibody screen, RPR, blood type and screen, hepatitis B screening, rubella status and HIV screening.  Results were not provided for these tests.  On 11-APR-2007, the patient started taking prenatal vitamins daily.  As of 03-MAY-2007, the patient had not reported any difficulties with her pregnancy.  On 05-OCT-2007, the patient was given BRETHINE 5 mg and PROCARDIA 10 mg every 4 hours for pre-term labor to stop her contractions.  There were reported to have discontinued on 14-NOV-2007.  On 20-NOV-2007, the patient gave birth to a liveborn female weighing 7 lbs. 11 oz.  She was 38 weeks from her last menstrual period.  The infant was reported to be normal and there were no congenital anomalies.  The infant was reported to have jaundice but no other symptoms.  At the time of this report the infant's and the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatitis B antibody, Pregnancy test negative, Premature labour, Rheumatoid factor, Rubella antibody test
Clinical narrative: Information has been received from a registered nurse through the Merck Pregnancy registry concerning an 18 year old white female with asthma and a penicillin allergy with a history of 0 pregnancies and 0 live births who on 29-NOV-2006 was vaccinated with a dose of Gardasil (Lot 654540/0800F).  On 13-FEB-2007, an HCG level was performed and was negative.  On 14-FEB-2007, she received her second vaccination (Lot 655619/1427F).  Concomitant therapy included albuterol.  On approximately 14-MAR-2007 the patient became pregnant (LMP 23-FEB-2007).  Laboratory diagnostic studies performed included CBC, prenatal antibody screen, RPR, blood type and screen, hepatitis B screening, rubella status and HIV screening.  Results were not provided for these tests.  On 11-APR-2007, the patient started taking prenatal vitamins daily.  As of 03-MAY-2007, the patient had not reported any difficulties with her pregnancy.  On 05-OCT-2007, the patient was given BRETHINE 5 mg and PROCARDIA 10 mg every 4 hours for pre-term labor to stop her contractions.  There were reported to have discontinued on 14-NOV-2007.  On 20-NOV-2007, the patient gave birth to a liveborn female weighing 7 lbs. 11 oz.  She was 38 weeks from her last menstrual period.  The infant was reported to be normal and there were no congenital anomalies.  The infant was reported to have jaundice but no other symptoms.  At the time of this report the infant's and the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syphilis test, Uterine contractions during pregnancy
Clinical narrative: Information has been received from a registered nurse through the Merck Pregnancy registry concerning an 18 year old white female with asthma and a penicillin allergy with a history of 0 pregnancies and 0 live births who on 29-NOV-2006 was vaccinated with a dose of Gardasil (Lot 654540/0800F).  On 13-FEB-2007, an HCG level was performed and was negative.  On 14-FEB-2007, she received her second vaccination (Lot 655619/1427F).  Concomitant therapy included albuterol.  On approximately 14-MAR-2007 the patient became pregnant (LMP 23-FEB-2007).  Laboratory diagnostic studies performed included CBC, prenatal antibody screen, RPR, blood type and screen, hepatitis B screening, rubella status and HIV screening.  Results were not provided for these tests.  On 11-APR-2007, the patient started taking prenatal vitamins daily.  As of 03-MAY-2007, the patient had not reported any difficulties with her pregnancy.  On 05-OCT-2007, the patient was given BRETHINE 5 mg and PROCARDIA 10 mg every 4 hours for pre-term labor to stop her contractions.  There were reported to have discontinued on 14-NOV-2007.  On 20-NOV-2007, the patient gave birth to a liveborn female weighing 7 lbs. 11 oz.  She was 38 weeks from her last menstrual period.  The infant was reported to be normal and there were no congenital anomalies.  The infant was reported to have jaundice but no other symptoms.  At the time of this report the infant's and the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Diarrhoea, Drug exposure during pregnancy, Nausea, Pregnancy test positive
Clinical narrative: Initial and follow up information has been received via the Merck pregnancy registry, from a certified medical assistant (CMA) concerning a 25 year old female patient, with a history of a recent spontaneous miscarriage (22-DEC-2006), a positive result for human papilloma virus (HPV) and mild dysplasia on a Papanicolaou (PAP) smear, who on 31-OCT-2006 was vaccinated IM, with the first dose of Gardasil (Lot #654540/0800F), and on 27-DEC-2006 was vaccinated with the second dose of Gardasil (lot #653938/0954F) (previously reported as lot #654540/0800F).  There was no concomitant medication.  On 09-FEB-2007, the patient had a positive pregnancy test; the date of the LMP was approximately 03-JAN-200, with an estimated date of delivery of 07-OCT-2007.  The CMA confirmed that there were no problems reported.  Follow up information from the CMA indicated ultrasound results on 12-FEB-2007, confirmed the patient was 6 weeks and 1 day into the gestation period, and again noted that there were no adverse experiences.  Additional follow up information from the CMA indicated that on 22-FEB-2007, the patient was administered IMODIUM for diarrhea, on 26-FEB-2007 she was prescribed ZOFRAN, prn, for nausea, and on 24-APR-2007, the was prescribed Z-PAK for a vaginal disorder (illegible).  On 28-SEP-2007, the patient delivered a 7 pound, normal male infant with an Apgar score of 9/9, with no complications reported during the pregnancy or delivery.  This patient also experienced a pregnancy following vaccination with the first dose of Gardasil (WAES #0705USA00787).  Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan, Vaginal disorder
Clinical narrative: Initial and follow up information has been received via the Merck pregnancy registry, from a certified medical assistant (CMA) concerning a 25 year old female patient, with a history of a recent spontaneous miscarriage (22-DEC-2006), a positive result for human papilloma virus (HPV) and mild dysplasia on a Papanicolaou (PAP) smear, who on 31-OCT-2006 was vaccinated IM, with the first dose of Gardasil (Lot #654540/0800F), and on 27-DEC-2006 was vaccinated with the second dose of Gardasil (lot #653938/0954F) (previously reported as lot #654540/0800F).  There was no concomitant medication.  On 09-FEB-2007, the patient had a positive pregnancy test; the date of the LMP was approximately 03-JAN-200, with an estimated date of delivery of 07-OCT-2007.  The CMA confirmed that there were no problems reported.  Follow up information from the CMA indicated ultrasound results on 12-FEB-2007, confirmed the patient was 6 weeks and 1 day into the gestation period, and again noted that there were no adverse experiences.  Additional follow up information from the CMA indicated that on 22-FEB-2007, the patient was administered IMODIUM for diarrhea, on 26-FEB-2007 she was prescribed ZOFRAN, prn, for nausea, and on 24-APR-2007, the was prescribed Z-PAK for a vaginal disorder (illegible).  On 28-SEP-2007, the patient delivered a 7 pound, normal male infant with an Apgar score of 9/9, with no complications reported during the pregnancy or delivery.  This patient also experienced a pregnancy following vaccination with the first dose of Gardasil (WAES #0705USA00787).  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Meconium increased, Ultrasound abdomen normal
Clinical narrative: Information has been received from a nurse, for the Pregnancy Registry for Gardasil concerning a 23 year old female with a history of papilloma viral infection and two live births who in December 2006, was vaccinated with Gardasil.  There was no concomitant medication.  The nurse reported that the patient is now pregnant.  The patient's LMP was 24-DEC-2006 and estimated due date was 30-SEP-2007.  The patient sought unspecified medical attention.  Follow-up information from the physician's office indicated that the patient had a routine ultrasound on 31-MAY-2007 which was normal (24.6 weeks).  The patient delivered a normal male baby on 03-SEP-2007, weighing 3375 grams, 19.5 inches long.  The infant was reported to have heavy meconium at delivery but was normal with an apgar score of 8/9 and no congenital anomalies.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Dizziness
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was going to be vaccinated with Gardasil (lot# unknown) late.  Follow-up information was received from a licensed practical nurse concerning a 19 year old white female with a "head cold" as per mother at the time of vaccination who on 19-DEC-2007 was vaccinated with a third dose of Gardasil (lot# 659439/1267U) IM in the left deltoid at 9:33 AM.  On 19-DEC-2007, at 9:41 AM after witnessing her sister have a syncope episode the patient felt dizzy.  The patient was assisted to the exam table.  The patient was in a supine position with her legs elevated with cold packs on neck and forehead.  The patient was continued to be monitored for 15 to 20 minutes.  The blood pressure measurement was 110/70.  On 19-DEC-2007 the patient recovered.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage, Metrorrhagia, Pregnancy test positive, X-ray of pelvis and hip
Clinical narrative: Information has been received through the pregnancy registry through a 23 year old female consumer who on 12-OCT-2007 was vaccinated with her first dose of Gardasil.  There was no concomitant medication.  On 20-OCT-2007, the patient had a pregnancy test which was positive (LMP approximately 25-SEP-2007).  The patient reports visiting the emergency room after finding out she was pregnant because she was experiencing some bleeding and spotting.  The patient had a "HCT Quantitative test" (not further specified).  She was not admitted to the hospital.  The patient reports having an "x-ray of hip while pregnant" (not further specified).  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant and a physician concerning a 15 year old female who on 26-OCT-2006 was vaccinated with the first dose of Gardasil. The patient was given the second dose on Gardasil on 13-NOV-2006. The patient experienced an allergic reaction not further specified. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Haemorrhage, Ultrasound abdomen normal
Clinical narrative: Initial and follow-up information has been received from the Pregnancy Registry via a registered nurse concerning an 19 year old white female with bipolar disorder who on 05-DEC-2006 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #653736/0868F).  On 05-FEB-2007, the patient was vaccinated intramuscularly with a 0.5 ml second dose of Gardasil (Lot #655617/1447F).  There was no concomitant medication.  Subsequently, the patient was pregnant.  Her last menstrual period was on 05-MAR-2007 and the estimated date of delivery was 10-DEC-2007.  On 17-MAY-2007, and ultrasound was performed for bleeding and was found to be normal.  The patient had an office visit.  At the time of the report the patient's outcome was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008. Initial and follow-up information has been received from the Merck Pregnancy Registry via a registered nurse concerning an 19 year old female with bipolar disorder who on 05-DEC-2006 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (Lot #653736/0868F). On 05-FEB-2007 the patient was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL (Lot #655617/1447F). There was no concomitant medication. Subsequently the patient was pregnant. Her last menstrual period was on 05-MAR-2007 and the estimated date of delivery was 10-DEC-2007. On 17-MAY-2007 an ultrasound was performed for bleeding and was found to be normal. The patient had an office visit. At the time of the report the patient's outcome was unknown. Follow-up information was received from the registered nurse. The patient had a healthy baby girl on 20-DEC-2007 weighing 8 pounds 7 ounces the length of the baby was 30 inches and the apgar score was 6/9. The patient was 41 wees from LMP. Pre-eclampsia complication was seen during the pregnancy. The baby had shoulder dystocia. On 26-JUL-2007 the patient had an ultrasound and was normal. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Medical device complication, Pain, Stress
Clinical narrative: Information has been received from a physician concerning patient who on 06-NOV-2007 was vaccinated with Gardasil. After administering a prefilled syringe to a patient the needle did not fully retract that the safety device did not fully cover the needle. Because of this the syringe became out of alignment. The patient's outcome was unknown. Product quality complaint was involved. Follow-up information was received from a physician. On 18-DEC-2007 the patient was vaccinated with a second dose of Gardasil (lot# 655327/1287U) 0.5 mL IM in the right deltoid. The physician used a Gardasil prefilled syringe and the safety mechanism failed to activate. Medical attention was sought. The physician felt that this increased stress and pain for the patient. At the time of reporting it was unknown if the patient recovered. No other information was provided. The SR # is 1-2166964843. Additional information is requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope
Clinical narrative: Information has been received from a physician's assistant concerning a 16 year old female who on 20-SEP-2007 and 05-DEC-2007 was vaccinated with a first a second dose of Gardasil.  On 05-DEC-2007 the patient went into the waiting room and fainted, fell to the floor.  Paramedics came in and the patient was out for about 20 seconds.  They elevated her legs and she seemed alright.  There was no major injury.  The representative (also reported as the nurse) called the patient's father on 08-DEC-2007.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain, Pregnancy test negative, Vaginal discharge
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 09-AUG-2007 was vaccinated with her first dose of Gardasil (lot# 656049/0187U). On 11-OCT-2007 the patient was vaccinated with her second dose of Gardasil (lot# 657621/0387U). On 12-OCT-2007 the patient experienced pelvic pain which did not subside and an unspecified vaginal discharge. On 18-OCT-2007 the patient was seen by the physician and the physician noted an absence of dysuria and fever. The patient was referred to a gynecologist. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan, Urinary tract infection, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received through the pregnancy registry, from a physician and a medical assistant (MA), concerning a 19 year old caucasian female patient with asthma, who on 12-FEB-2007 was vaccinated IM in the right arm, with the first dose, 0.5ml, of Gardasil (Lot #655619/1427F).  There was no concomitant medication.  The MA reported that on 27-FEB-2007, the patient called the office to report she had performed a urine home pregnancy test that was positive.  On 19-MAR-2007, the patient visited the office and an ultrasound test also confirmed the pregnancy.  At that time, vitamin and mineral therapy with PRENATE ELITE was initiated on a daily basis.  The date of the LMP was 16-JAN-2007, with an estimated date of delivery on 23-OCT-2007.  Follow up information from the physician, indicated that from 19-JUL-2007 to 25-JUL-2007, the patient was treated for a urinary tract infection with nitrofurantoin (MACROBID), but she indicated there were no complications during the pregnancy.  Additional ultrasounds were performed on 29-MAY-2007 and 20-SEP-2007 (results not provided).  On 11-OCT-2007, at 38 weeks gestation, the pregnancy resulted in the uncomplicated delivery of a normal male infant (weight not provided).  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning his daughter who was vaccinated with Gardasil and fainted. Subsequently, the patient recovered from fainting. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Full blood count normal, Laboratory test abnormal, Lymphadenopathy, Rheumatoid factor positive, Ultrasound scan abnormal
Clinical narrative: Information has been received from a health professional concerning a 14 year old female who was vaccinated with Gardasil. On 29-NOV-2007 the patient experienced lymphadenopathy. The patient's outcome was not reported. Follow-up information has been received from a physician concerning a 13 year old (also reported as 14 year old) female with a penicillin allergy and allergic reaction to antibiotics with SEPTRA and CEFZIL who on 13-NOV-2006 was vaccinated with a first dose of Gardasil (lot# 653978/0955F) IM in the left arm. Concomitant therapy included Varivax. Other concomitant therapy included Hepatitis A virus vaccine (unspecified). On 05-DEC-2006, the patient came to the office. On 03-DEC-2006 the patient experienced swollen tender lymph nodes behind the left ear. The outcome was not reported. On 05-DEC-2006 Concomitant therapy included an infuenza virus vaccine (unspecified). On 15-JAN-2007 the patient was vaccinated with a second dose of Gardasil (lot# 654389/0961F) IM in the left arm. On 02-MAY-2007 the patient experienced swollen lymph nodes. On 02-MAY-2007 an ultrasound was performed to assess the mastoid area which showed redness and inflammation. The impression was there was a 1.6 x 0.8 x 1.0 cm lymph over the right mastoid. Otherwise normal soft tissue view over the mastoid area. The outcome was not reported. On 13-JUN-2007 the patient was vaccinated with a third dose of Gardasil (lot# 657868/0523U) IM in the left arm. On 13-JUN-2007 the patient was presented with lymph nodes in the cervical region. The patient had been treated for a cat scratch with improvement. The outcome was not reported. On 24-JUL-2007, the patient had a biopsy of the right mastoid lymph node and revealed lymph node with sclerosis and reactive features, no tumor was identified. A left check lymph node revealed reactive hyperplasia and no tumor was identified. Flow cytometry lymph node biopsy left cheek revealed no diagnostic lymphoid abnormality identified. No abnormalities of the B-lymphocytes are noted. No light chain restriction is noted on the CD+19 B-lymphocytes. On 04-SEP-2007 the patient experienced lymph nodes under the chin. On 14-SEP-2007 an ultrasound was performed to assess a palable lump. The impression was two sonolucent solid areas under the mandible presumed to be lymph nodes. On 03-DEC-2007, the patient was vaccinated with an influenza virus vaccine (unspecified) and hepatitis A vaccine (unspecified). On 03-DEC-2007, the patient complained of lymphadenopathy. On 10-DEC-2007 a complete blood cell count was performed and the results were normal. Cat scratch AB panel showed positive for bartonella henselae. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pruritus, Vaccine positive rechallenge
Clinical narrative: Information has been received from the mother of an 18 year old female consumer with a history of "reaction to dioxycycline" who in March 2007, was vaccinated with the first dose of Gardasil.  On May 2007 the patient was vaccinated with the second dose of Gardasil.  Subsequently the patient experienced itching on the injection site and headache after receiving the first and second dose of Gardasil.  The patient's mother reported the patient's status as "patient is fine."  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Drug administered at inappropriate site
Clinical narrative: Information has been received from a physician assistant concerning a 15 year old female who on 03-DEC-2007 was vaccinated IM in the hip with the first 0.5 mL dose of Gardasil.  On 04-DEC-2007 the patient experienced hip, knee and ankle pain.  Subsequently, the patient recovered from hip, knee and ankle pain.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who was vaccinated intramuscularly with Gardasil and experienced lymphadenopathy.  The patient sought unspecified medical attention and her outcome was not reported.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 23-JUL-2007 was vaccinated intramuscularly with her first dose of Gardasil (lot# 658100/0525U).  On 22-OCT-2007 the patient was vaccinated intramuscularly with her second dose of Gardasil (lot# 658556/1060U).  On 19-NOV-2007 the patient experienced an abnormal Pap with results of atypical squamous cells of undetermined significance.  The patient's abnormal Pap and atypical squamous cells of undetermined significance persisted. The patient sought medical attention in the office.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diagnostic procedure, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 02-OCT-2007 was vaccinated with her first dose of Gardasil (lot #657621/0387U) injection.  Concomitant therapy included MENACTRA.  On 02-OCT-2007, after receiving the vaccine, the patient fainted.  Subsequently, the patient recovered from fainting.  She sought unspecified medical attention.  The office is not sure whether or not the patient will received the second dose.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a physician concerning multiple patients who were vaccinated with Gardasil.  Subsequently the patients experienced injection site reactions after receiving Gardasil.  The nurse reported that about 5-10 patients experienced a lot of heat and a knot under the skin for about a week after the vaccine.  The patients sought unspecified medical attention and their outcome was not reported.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a patient (age and gender not reported) who on 11-DEC-2007 was vaccinated (route and site not reported) inadvertently with a dose of Gardasil (lot# not reported) instead of Pneumovax 23.  The incident was due to human error and there was no product confusion.  The patient did not experience any known symptoms.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Lymphadenopathy, Smear cervix abnormal
Clinical narrative: Information has been received from a physician, concerning a 19 year old female patient with a history of papilloma viral infection (26-SEP-2007), who in October 2007, was vaccinated in the upper thigh with the first dose of Gardasil (lot # not provided).  Two weeks after the vaccination, the patient developed lymphadenopathy in her inguinal area.  The patient presented to the office for evaluation, and it was determined that she had bilateral lymphadenopathy.  Diagnostic tests included a complete blood count, with normal results.  The physician indicated that the patient had no sexually transmitted diseases.  At the time of this report, the patient had recovered from the event.  Additional information has been requested.