chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Patient complaining of 6 inch red streak on Right arm at site of Zostavax immunization.  States it is warm to the touch and swollen.
Age: 23.0
Sex: M
Vaccine: HEPAB
Symptoms: Guillain-Barre syndrome, Respiratory distress
Clinical narrative: Guillain-Barre syndrome.  Sx beginning 12 days post vaccine.  Hospitalized 6 days.  07/23/2008 MR received for DOS 7/4-9/2008 with D/C DX:  Guillain-Barre Syndrome.  Pt presented with 5 dya hx of paresthesias, weakness and pain to hands, face and legs, decreased taste sensation and progressive difficulty with walking and standing.  Recent onset of SOB. PE (+) for pulse 116, accessory muscle use for breathing, diffuse abd tenderness, cold extremities, bilateral cranial nerve 7 palsy, weak DTRs, and bilateral weakness.  TX with IVIG with good response in all but facial palsy. Able to ambulate with walker.  D/C for outpt f/u and tx.
Age: 1.25
Sex: F
Vaccine: MMR, PNC
Symptoms: Lethargy, Moaning, Tremor, Vomiting
Clinical narrative: Vomiting, tremors in arms & legs for 1-2 minutes with moaning and lethargy following.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: PT WAS GIVEN ZOSTAVAX SQ TO LEFT ARM ON 7/8 BY TODAY PT HAS DEVELOPED REDDENED AREA SYMETRICAL IN NATURE AROUND INJECTION SITE. DARKER RED IN CENTER  MEASURES 2.2 X 2CM WITH LIGHTER RED RING AROUND. MEASURED TOTAL AREA  9CM X 8.5 CM HARDENED AREA IN CENTER AND WARM TO TOUCH THROUGHOUT. C/O PAIN TO SITE. OTHER SYMPTOMS ALSO INCLUDE HA,MUSCLE ACHE, AND JOINT PAINS. TX BY PA-C BENEDRYL 25MG Q4HRS PRN, TYLENOL PRN, COOL COMPRESS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia
Clinical narrative: PT WAS GIVEN ZOSTAVAX SQ TO LEFT ARM ON 7/8 BY TODAY PT HAS DEVELOPED REDDENED AREA SYMETRICAL IN NATURE AROUND INJECTION SITE. DARKER RED IN CENTER  MEASURES 2.2 X 2CM WITH LIGHTER RED RING AROUND. MEASURED TOTAL AREA  9CM X 8.5 CM HARDENED AREA IN CENTER AND WARM TO TOUCH THROUGHOUT. C/O PAIN TO SITE. OTHER SYMPTOMS ALSO INCLUDE HA,MUSCLE ACHE, AND JOINT PAINS. TX BY PA-C BENEDRYL 25MG Q4HRS PRN, TYLENOL PRN, COOL COMPRESS.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Anorexia, Insomnia, Pain, Pyrexia, Vomiting
Clinical narrative: Fever of 105, vomiting, loss of appetite, pain, sleeplessness.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Oedema peripheral, Pain
Clinical narrative: Severe left arm swelling, pain and cellulitis.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood pressure, Dizziness, Heart rate, Nausea, Pallor
Clinical narrative: After vaccine administration, patient became lightheaded, pale and nauseated. Did not want to lie down, felt better sitting with head on exam table. Gave soda to drink. HR=68-B/P 100/62. Stayed in office for 50 minutes. All symptoms resolved patient discharged to home.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Mom spoke to on-call doctor, did not have office visit. Mom reports 4" swelling, raised red & hard. Mom gave ibuprofen, BENADYL, ice and heat. Today symptoms are improving. No fever. Swelling was in left arm.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chills, Influenza like illness, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: Received GARDASIL in right deltoid & MENACTRA in left deltoid on 06/30/08, Monday. Monday afternoon started with Flu-like symptoms. Fever & chills, swelling right arm, body aches. No redness at injection site but swelling.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pyrexia
Clinical narrative: Received GARDASIL in right deltoid & MENACTRA in left deltoid on 06/30/08, Monday. Monday afternoon started with Flu-like symptoms. Fever & chills, swelling right arm, body aches. No redness at injection site but swelling.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Crying, Cyanosis, Dyspnoea, Heart rate increased, Intercostal retraction
Clinical narrative: NOTE: ACUTE RESP DISTRESS APPROX 15 MINUTES AFTER IMMS ADMINISTERED.  Mom noted child suddenly crying and then having difficulty breathing.  She called for nurse who then called me to see child.  I found child crying with moderate cyanosis.  Chest-poor air entry with faint insp and exp wheezes throughout and intercostal retractions.  Back to treatment room, called 911.  Initial pulse ox=88%, HR=133.  Placed immed on O2 via nasal cannuli at 3 liters with immed improvement of pulse ox to 100% after 1 minute.  Also started albuterol neb .5ml/3ml along with O2.  Suctioned oral secretions x1 with bulb syringe.  Much improved, acyanotic, swallowing secretions well with better air entry.  During neb treatment, retractions resolved, wheezes persisted.  On continuous pulse ox monitor which =99%-100%.  Ambulance arrived, child transported with O2 via nasal cannuli to ER.  Mom accompanied.  8/28/2008 MR received for DOS 7/11-12/2008 with DX: Wheezing, Choking episode. Infant developed acute onset of wheezing associated with cyanosis after 6 month vax. Mother reported choking with crying after vax. Initially treated with albuterol nebs, O2 and suctioning then transported via EMS to local hospital then transferred to higher level of care. Good response to albuterol. No rash, lip swelling, V&D initially. Observed o/n. Later that pm developed urticarial rash to face, neck, chest and back with peri-orbital edema, pruritis and 1 large emesis with upper airway congestion. Tx with Benadryl. Given epi-pen for home use and referred to allergist as outpt.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Laboratory test normal, Oxygen saturation decreased, Respiratory distress, Wheezing
Clinical narrative: NOTE: ACUTE RESP DISTRESS APPROX 15 MINUTES AFTER IMMS ADMINISTERED.  Mom noted child suddenly crying and then having difficulty breathing.  She called for nurse who then called me to see child.  I found child crying with moderate cyanosis.  Chest-poor air entry with faint insp and exp wheezes throughout and intercostal retractions.  Back to treatment room, called 911.  Initial pulse ox=88%, HR=133.  Placed immed on O2 via nasal cannuli at 3 liters with immed improvement of pulse ox to 100% after 1 minute.  Also started albuterol neb .5ml/3ml along with O2.  Suctioned oral secretions x1 with bulb syringe.  Much improved, acyanotic, swallowing secretions well with better air entry.  During neb treatment, retractions resolved, wheezes persisted.  On continuous pulse ox monitor which =99%-100%.  Ambulance arrived, child transported with O2 via nasal cannuli to ER.  Mom accompanied.  8/28/2008 MR received for DOS 7/11-12/2008 with DX: Wheezing, Choking episode. Infant developed acute onset of wheezing associated with cyanosis after 6 month vax. Mother reported choking with crying after vax. Initially treated with albuterol nebs, O2 and suctioning then transported via EMS to local hospital then transferred to higher level of care. Good response to albuterol. No rash, lip swelling, V&D initially. Observed o/n. Later that pm developed urticarial rash to face, neck, chest and back with peri-orbital edema, pruritis and 1 large emesis with upper airway congestion. Tx with Benadryl. Given epi-pen for home use and referred to allergist as outpt.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Blood pressure increased, Body temperature, Heart rate normal, Induration, Oedema peripheral
Clinical narrative: Patient received 2 injections in right arm on 07-10/08 at her doctors office. Came to urgent care with pain and swelling in right upper arm (7-8 cm induration) given Keflex 500 mg qid for 5 days.
Age: 72.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Respiratory rate
Clinical narrative: Patient received 2 injections in right arm on 07-10/08 at her doctors office. Came to urgent care with pain and swelling in right upper arm (7-8 cm induration) given Keflex 500 mg qid for 5 days.
Age: 46.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Dizziness, Feeling hot, Pain in extremity, Syncope
Clinical narrative: 47 year old female received below vaccines, reports 3 1/2 later worsening pain in right arm, felt dizzy and hot. Witnessed syncopal episode by husband (physician) approximately 10 second duration. No rash or other symptoms. Recovered without problems. Has history of syncopal episode after PCN shot & PPD test many years ago. Near syncopal episode one year ago from severe pain after tooth injury (cracked).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Patient stopped by office today: He received 4 immunizations 2 days ago, 2 on right upper arm, and 2 on left upper arm. On the left deltoid are, where he received Tdap #5, there is blistering in a square-ish pattern, where there was a bandaid, and the the area is not and red, extending down to the lower area of the deltoid muscle. The other injection sites were given bandaids, but no blistering developed at the other sites. He has been active and playful, and is using his left arm without problem. Plan: MOTRIN susp 1 1/2 tsp given po here at 5:05 pm, to repeat q 6-8 hrs, while awake through tomorrow. Mother was advised to purchase BENADRYL syrup and to give it to him as soon as she gets it, and to repeat q 6 hrs while awake, through tomorrow. NEOSPORIN to blistering area. Cool compresses to area. Follow over weekend if symptoms worsen.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Hypertonia
Clinical narrative: 4 hours after vaccines patient has had frequent hypertonic episodes lasting a few seconds to minutes. No loss of consciousness.
Age: 79.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral, Palpitations
Clinical narrative: Swelling and redness that started on site of my injection that progressed distally as per pt. On exam, note of pain on palpation of her site of injection. Left arm w\o any redness/swelling over the area; redness/swelling/tenderness/warmthness over inner upper left arm.
Age: 79.0
Sex: F
Vaccine: PPV, TD
Symptoms: Skin warm, Tenderness
Clinical narrative: Swelling and redness that started on site of my injection that progressed distally as per pt. On exam, note of pain on palpation of her site of injection. Left arm w\o any redness/swelling over the area; redness/swelling/tenderness/warmthness over inner upper left arm.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Got dizzy, nauseated about 5-10 minutes after shot, had her sit down eat some crackers, headache.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash, Urticaria
Clinical narrative: Rash was first noticed on 07-10-08. Raised, whelps and rash starting on trunk area spreading down bilateral arms and legs. Concentrated rash area noted on abdomen around waist band. Denies any other problems.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Vaccination complication, Varicella
Clinical narrative: Rash identified by RN as chickenpox 07/07/08 after Varicella vaccine given to child 07/01/08. "Rash" mild <50 lesion reported by mother.
Age: 27.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Blister
Clinical narrative: Pt. woke this A.M. with 3 large blisters to R thigh. Approximately 9" in length. Seen by PCP today who thinks it is unrelated. ? impetigo.
Age: 1.62
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Blood culture negative, Cellulitis, Erythema, Full blood count normal, Oedema peripheral
Clinical narrative: 20 month old female received DTAP and HEPATIS A vaccines into the left and right thighs respectively on 19 Jun 2008. Some 24 hours later, the mother noticed increased redness and swelling over the left anterior-lateral thigh. The physician-father attempted to treat the "presumed infection" with a dose of Augmentin initially, and then later, a dose of Zithromax. The child was not febrile, anorectic, malaised or decreased in her activity. She was ambulating fine without complaints. The parents took the child to the clinic on 6/21/08 for evaluation. The pediatric attending saw the patient and admitted her to the ward with a diagnosis of "cellulitis". The child was discharged the following day, 22 June 2008, after a few doses of IV Clindamycin. 10/6/08-records received for DOS 6/21-6/22/08-DC DX: Cellulitis of left anterior thigh after immunizations. Presented to ED with C/O worsening erythema of left anterolateral thigh following vaccine immunization on 6/19/08. Site of vaccination appeared swollen and tender. Treated with IV antibiotics.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Pain, Pharyngolaryngeal pain, Swelling face
Clinical narrative: facial swelling, generalized body rash, feeling of sore throat. Epinephrine and Benadryl.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy, Ultrasound abdomen
Clinical narrative: Initial and follow up information has been received through a physician and a nurse for the Pregnancy Registry for GARDASIL regarding a 17 year old female, with attention deficit/hyperactivity disorder, and no known previous pregnancies, who on 21-MAY-2007 was vaccinated with her first dose of GARDASIL (Lot # 657621/0387U; route and site not reported).  On 09-JUL-2007, the patient was vaccinated with her second dose of GARDASIL (Lot # 658490/0802U; route and site not reported).  On 22-OCT-2007, the patient was vaccinated with influenza virus vaccine (unspecified).  On 26-NOV-2007, the patient was vaccinated with her third dose of GARDASIL (Lot # 659437/1266U; route and site not reported).  Concomitant therapy included FOCALIN and FOCALIN XR.  On 31-DEC-2007, the patient was diagnosed with scabies and treated with ATARAX and ELIMITE cream.  On 03-JAN-2008, the patient had an ultrasound due to an enlarged abdomen.  The results of the ultrasound showed that the patient was pregnant (33.7 weeks gestational age).  The patient's LMP was reported as November 2007.  On 23-JAN-2008, the patient gave birth to a normal baby girl (5 lbs, 13 oz and 18 in).  There were no congenital anomalies.  There were no complications during labor and delivery.  It was reported that the patient had no prenatal care.  No additional information was provided.  No additional information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound abdomen
Clinical narrative: Information has been received from a Merck Pregnancy Registry for GARDASIL from a registered nurse concerning an 18 year old female, with no drug reactions or allergies, with a history of anaemia, who on 23-AUG-2007 was vaccinated, intramuscularly, with the first 0.5 mL dose of GARDASIL.  Concomitant therapy included prenatal vitamins (unspecified).  The patient was subsequently determined to be pregnant, and had an exam in the office.  The patient had an abdominal ultrasound.  Her last menstrual period was 24-JUN-2007 and estimated delivery date was 30-MAR-2008.  No problems were reported.  No further details were available.  Follow up phone call information was received from a nurse who reported that the patient delivered a normal, healthy baby in March 2008.  The baby was checked by a pediatrician and everything was fine.  No anomalies were found.  No additional information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter for the Pregnancy Registry for GARDASIL who on 28-MAR-2007 was vaccinated with her first dose of GARDASIL (lot# not reported).  On 30-JUL-2007 the patient was vaccinated with her second dose of GARDASIL (lot# not reported) and was pregnant.  On 08-AUG-2007 the patient was vaccinated with her third dose of GARDASIL (lot# not reported).  The date of conception was 22-JUL-2007 (LMP approximately 14-JUL-2007).  The patient sought unspecified medical attention and her outcome is unknown.  Attempts were made to receive additional information, but this case has been lost to follow-up.  No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a registered nurse through the Merck Pregnancy Registry concerning an 18 year old female patient with no known medical history or drug reactions/allergies, who on 25-JAN-2007, was vaccinated intramuscularly in the left deltoid with the first 0.5 mL dose of GARDASIL (lot# 654702/0011U).  On 27-APR-2007 the patient was vaccinated intramuscularly in the left deltoid with the second 0.5 mL dose of GARDASIL (lot# 657006/0188U).  On 07-AUG-2007 the patient was vaccinated intramuscularly in the left deltoid with the third 0.5 mL dose of GARDASIL (lot# 658100/0525U).  There was no concomitant medication.  The nurse reported that after receiving three doses of GARDASIL the patient is now pregnant.  The patient's last menstrual period was on 20-JUL-2007.  Her estimated conception date was 04-AUG-2007 which changed her estimate delivery date to 26-APR-2008.  An ultrasound done on the 10-DEC-2007 confirmed the change of her EDC.  Unspecified medical attention was sought.  It was also reported that the patient has not had any previous pregnancies or live births.  At the time of this report, the patient's outcome was unknown.  Follow up information by an other health professional confirmed that the baby was born and enrolled in a program but she could not provide any additional details at this time.  There was no product quality complaint.  Follow up information stated that on 28-APR-2008, the patient gave birth to a liveborn infant female weighing 8 pounds 12 ounces.  Her APGAR score was reported as 8 - 9.  The patient was 41 weeks from her last menstrual period.  The infant's head circumference was 13 inches.  The infant was reported as normal with no congenital anomalies.  There were no complications or abnormalities reported during the pregnancy or labor/delivery.  At the time of this report, the patient recovered.  On 14-JUL-2008, follow up information stated that the baby was now 2 months old and "seems fine."  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Echocardiogram normal, Pregnancy test negative, Ultrasound antenatal screen normal
Clinical narrative: Initial and follow-up information has been received from the Merck pregnancy registry via a registered nurse concerning a 22 year old female smoker with a history of depression with no treatment medications, 2 previous pregnancies, 1 full term delivery at 38 weeks, 1 elective termination, and a cousin with open neural tube defect, who on 24-JUL-2007 was vaccinated IM, into the left deltoid, with a 0.5 ml first dose of GARDASIL (lot # 658822/0927U).  It was reported that a pregnancy test was negative at the time of vaccination.  Subsequently, the patient became pregnant.  The patient's last menstrual period was 14-JUL-2007 and the estimated date of delivery was 19-APR-2008.  On 13-AUG-2007 the patient was started on VITAFOL-B, once a day.  On 17-SEP-2007 an ultrasound was performed for routine viability source and dating, and the results were intrauterine pregnancy and a positive fetal heart.  On 10-OCT-2007 the patient showed to be positive for Coxsackie B titers.  On 15-OCT-2007 the patient was vaccinated with a 0.5 mL dose of influenza virus vaccine (unspecified).  On 12-NOV-2007 a Maternal Serum Alpha-Fetoprotein Screening was performed for genetic screening, and the results were within normal limits.  On 15-NOV-2007 a level II ultrasound was performed for genetic screening and fetal anatomy, and the results were within normal limits.  On 18-DEC-2007 a fetal echocardiography was performed and was within normal limits.  On 31-JAN-2007 at 28 weeks gestation the patient received a 300 microgram dose of globulin, immune because she was Rh negative.  Unspecified medical attention was sought.  At the time of the report, the patient's outcome was unknown.  On 12-APR-2008 the patient gave birth to a female infant at 39 weeks.  The infant weighed 6 pounds 3 ounces, was 18.5 inches long, had an apgar score of 8/9, and a head circumference of 32cm.  The infant was normal with no congenital anomalies, complications, or abnormalities.  The patient experienced Leukocytosis, Bandemia, and positive Coxsackie B titers during pregnancy.  At the time of the report the patient had recovered from leukocytosis and bandemia.  The outcome of the positive Coxsackie B titers was unknown.  Additional information is not available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Initial and follow-up information has been received from the Merck pregnancy registry via a registered nurse concerning a 22 year old female smoker with a history of depression with no treatment medications, 2 previous pregnancies, 1 full term delivery at 38 weeks, 1 elective termination, and a cousin with open neural tube defect, who on 24-JUL-2007 was vaccinated IM, into the left deltoid, with a 0.5 ml first dose of GARDASIL (lot # 658822/0927U).  It was reported that a pregnancy test was negative at the time of vaccination.  Subsequently, the patient became pregnant.  The patient's last menstrual period was 14-JUL-2007 and the estimated date of delivery was 19-APR-2008.  On 13-AUG-2007 the patient was started on VITAFOL-B, once a day.  On 17-SEP-2007 an ultrasound was performed for routine viability source and dating, and the results were intrauterine pregnancy and a positive fetal heart.  On 10-OCT-2007 the patient showed to be positive for Coxsackie B titers.  On 15-OCT-2007 the patient was vaccinated with a 0.5 mL dose of influenza virus vaccine (unspecified).  On 12-NOV-2007 a Maternal Serum Alpha-Fetoprotein Screening was performed for genetic screening, and the results were within normal limits.  On 15-NOV-2007 a level II ultrasound was performed for genetic screening and fetal anatomy, and the results were within normal limits.  On 18-DEC-2007 a fetal echocardiography was performed and was within normal limits.  On 31-JAN-2007 at 28 weeks gestation the patient received a 300 microgram dose of globulin, immune because she was Rh negative.  Unspecified medical attention was sought.  At the time of the report, the patient's outcome was unknown.  On 12-APR-2008 the patient gave birth to a female infant at 39 weeks.  The infant weighed 6 pounds 3 ounces, was 18.5 inches long, had an apgar score of 8/9, and a head circumference of 32cm.  The infant was normal with no congenital anomalies, complications, or abnormalities.  The patient experienced Leukocytosis, Bandemia, and positive Coxsackie B titers during pregnancy.  At the time of the report the patient had recovered from leukocytosis and bandemia.  The outcome of the positive Coxsackie B titers was unknown.  Additional information is not available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received from a healthcare worker and a certified medical assistant through the Pregnancy Registry for GARDASIL regarding a 19 year old female with a history of seasonal allergies who on 04-JUN-2007 was vaccinated with her first dose of GARDASIL (Lot # 655617/1447F; site and route not reported).  On 13-Aug-2007, the patient was vaccinated with her second dose of GARDASIL (Lot #, site and route not reported).  On 05-Sep-2007 it was reported that the patient was pregnant.  The patient sought unspecified medical attention in the office.  The patient had a urine pregnancy test which was positive.  "The LMP is unspecified, but the physician believes that the patient is within the first month of pregnancy."  On 08-MAY-2008, the patient delivered a normal baby boy (9lbs, 5 oz and 22 1/4 inches) at 40 weeks gestation.  The baby's Apgar scores were 8 and 9.  The baby was healthy "other than slight jaundice treated with bili light".  There were no congenital anomalies or abnormalities.  There were no complications with the pregnancy, labor or delivery.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry via a licensed practical nurse concerning a 20 year old female with a history of social alcohol use in the first and second week until pregnancy confirmed who on 18-JUL-2007 was vaccinated intramuscularly with a first dose of GARDASIL.  Concomitant therapy included SKELAXIN five times total for a muscle relaxant and ADVIL 200 mg (frequency not reported).  Subsequently the patient was five months pregnant and did not realize it.  The patient was a Gravida 1, Para 0.  The patient's last menstrual period was in early February 2007 and the date of conception was on 14-FEB-2007.  At 25 weeks gestation the patient visited the physician for her 1st obstetric appointment.  On 23-JUL-2007 an ultrasound was performed to confirm pregnancy revealing a 25 week gestation.  On 30-JUL-2007 another ultrasound was performed that revealed an intra-uterine pregnancy at 25 4/7 weeks gestation and confirmed male fetus.  On 06-NOV-2007, at thirty nine and five days from the LMP the patient delivered a normal male infant.  Labor and delivery were uncomplicated.  The apgar scores were 9 and 9.  At the time of the report the patient had recovered.  Follow up information was received on 28-MAR-2008 from the physician's office.  The mother called the physician's office on 07-JAN-2008 at 1:43 pm and reported that the infant was 2 months old and had a stuffy nose, sneezing and watery eyes.  The infant also had a slight temperature of 100 degrees on 06-JAN-2008.  On 7-JAN-2008 at 1:55 pm it was noted to observe the infant and do DIMETAPP and ADVIL/MOTRIN.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received for the Pregnancy Registry for GARDASIL from a nurse practitioner concerning a female (age not reported) who was vaccinated with a first dose of GARDASIL (lot# unknown) injection.  Subsequently the patient received her first dose 8 days post conception.  Medical attention was sought.  No adverse experience was reported.  The date of the last menstrual period and the estimated date of delivery is unknown.  Follow-up information was received from a nurse practitioner.  The female patient was 21 years old with no pertinent medical history and no drug reactions/allergies.  There was no concomitant medication.  The patient's date of last menstrual period was 14-JUL-2007 and on 16-JAN-2008 the patient was 26 weeks gestation.  The patient had a shortened cervix (unknown if this was a condition prior to pregnancy).  On 06-AUG-2007 the patient received a first dose of GARDASIL (unknown if this was the first or second dose) from her primary physician.  On 20-AUG-2007 the patient had a positive pregnancy test.  The nurse mentioned the pregnancy was going well.  The estimated date of delivery is 19-APR-2008.  The patient delivered a female baby on 21-APR-2008.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from a Nurse Practitioner concerning a 26 year old female with anemia and a history of cutaneous intraepitheleal neoplasia who on 02-JUL-2007 was vaccinated IM with a first dose of GARDASIL lot #658100/0525U.  Concomitant therapy included hormonal contraceptives (unspecified), prenatal vitamins, PROMETRIUM, and SLOW FE.  Last menstrual period was the end of JUN-2007.  Estimated delivery date was 05-APR-2008.  Subsequently, the patient became pregnant and it was confirmed by a home pregnancy test.  She was not experiencing any known symptoms.  Unspecified medical attention was sought by the patient.  There were no reported complications during the pregnancy.  On 15-MAR-2008, the patient delivered a normal set of twins, one male 6 pounds and 4 ounces, and one female 6 pounds 1 ounce.  There were no congenital anomalies and no reported complications or abnormalities.  No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Blood glucose, Blood grouping, Drug administered at inappropriate site, Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck pregnancy registry from a licensed practical nurse concerning an 18 year old female smoker with a penicillin allergy who on 09-NOV-2006 was vaccinated in the left buttocks with the first dose of GARDASIL (Lot #653735/0688F).  Concomitant therapy included NUVARING, LOESTRIN 24 FE and prenatal vitamins (unspecified).  On 04-JAN-2007, the patient was vaccinated in the right gluteal with the second dose of GARDASIL (Lot #655765/1425F).  It was reported that the patient was pregnant, after receiving the vaccine.  Her last menstrual period was reported as 13-MAR-2007 and estimated due date 18-DEC-2007.  On an unspecified date in 2007, the patient had the following infections or illnesses during pregnancy gestational diabetes mellitus and anemia.  On 07-MAY-2007, an ultrasound was performed results reported were 7 6/7 IUG which confirmed the pregnancy.  On 20-JUL-2007, a pregnancy quad screen and ultrasound were performed results were within normal limits.  On 29-SEP-2007, 1 hour glucose "HcH" was performed results were not reported.  On 18-OCT-2007, an ultrasound was performed results were within normal limits.  On 03-DEC-2007, an ultrasound was performed results were within normal limits.  On 17-DEC-2007 (39 4/7 weeks gestation), it was reported that the patient delivered a normal healthy baby girl, weight 7lbs 8 oz and Apgar score was 8/9.  No congenital anomalies, complications or abnormalities were reported.  The seriousness and outcome of the GDMA and anemia were not reported.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Gestational diabetes, Glucose tolerance test, Syphilis test negative, Thyroid function test normal
Clinical narrative: Information has been received through the Merck pregnancy registry from a licensed practical nurse concerning an 18 year old female smoker with a penicillin allergy who on 09-NOV-2006 was vaccinated in the left buttocks with the first dose of GARDASIL (Lot #653735/0688F).  Concomitant therapy included NUVARING, LOESTRIN 24 FE and prenatal vitamins (unspecified).  On 04-JAN-2007, the patient was vaccinated in the right gluteal with the second dose of GARDASIL (Lot #655765/1425F).  It was reported that the patient was pregnant, after receiving the vaccine.  Her last menstrual period was reported as 13-MAR-2007 and estimated due date 18-DEC-2007.  On an unspecified date in 2007, the patient had the following infections or illnesses during pregnancy gestational diabetes mellitus and anemia.  On 07-MAY-2007, an ultrasound was performed results reported were 7 6/7 IUG which confirmed the pregnancy.  On 20-JUL-2007, a pregnancy quad screen and ultrasound were performed results were within normal limits.  On 29-SEP-2007, 1 hour glucose "HcH" was performed results were not reported.  On 18-OCT-2007, an ultrasound was performed results were within normal limits.  On 03-DEC-2007, an ultrasound was performed results were within normal limits.  On 17-DEC-2007 (39 4/7 weeks gestation), it was reported that the patient delivered a normal healthy baby girl, weight 7lbs 8 oz and Apgar score was 8/9.  No congenital anomalies, complications or abnormalities were reported.  The seriousness and outcome of the GDMA and anemia were not reported.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received through the Merck pregnancy registry from a licensed practical nurse concerning an 18 year old female smoker with a penicillin allergy who on 09-NOV-2006 was vaccinated in the left buttocks with the first dose of GARDASIL (Lot #653735/0688F).  Concomitant therapy included NUVARING, LOESTRIN 24 FE and prenatal vitamins (unspecified).  On 04-JAN-2007, the patient was vaccinated in the right gluteal with the second dose of GARDASIL (Lot #655765/1425F).  It was reported that the patient was pregnant, after receiving the vaccine.  Her last menstrual period was reported as 13-MAR-2007 and estimated due date 18-DEC-2007.  On an unspecified date in 2007, the patient had the following infections or illnesses during pregnancy gestational diabetes mellitus and anemia.  On 07-MAY-2007, an ultrasound was performed results reported were 7 6/7 IUG which confirmed the pregnancy.  On 20-JUL-2007, a pregnancy quad screen and ultrasound were performed results were within normal limits.  On 29-SEP-2007, 1 hour glucose "HcH" was performed results were not reported.  On 18-OCT-2007, an ultrasound was performed results were within normal limits.  On 03-DEC-2007, an ultrasound was performed results were within normal limits.  On 17-DEC-2007 (39 4/7 weeks gestation), it was reported that the patient delivered a normal healthy baby girl, weight 7lbs 8 oz and Apgar score was 8/9.  No congenital anomalies, complications or abnormalities were reported.  The seriousness and outcome of the GDMA and anemia were not reported.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Blood pressure, Drug exposure during pregnancy, Pre-eclampsia, Ultrasound uterus
Clinical narrative: Information has been received from the step-mother of a 21 year old female and through a Merck Pregnancy Registry.  The 21 year old female had no pertinent medical history and no drug reactions or allergies who on approximately 16-APR-2007, "approximately 2 weeks ago" was vaccinated "in the hip area" with the first dose of GARDASIL.  The lot number was not available.  There was no concomitant medication.  It was reported that the patient discovered that she was pregnant approximately a week and a half later on 27-APR-2007.  The patient had not visited her physician regarding the pregnancy as of today.  It was reported that the patient was approximately 6 weeks pregnant.  In follow-up it was reported by a nurse practitioner, who was a nurse midwife concerning a 21 year old, female, patient, with the last menstrual period was 16-MAR-2007, who on 20-APR-2007 received her first dose of GARDASIL, (Lot # 657006/0188U).  It was reported that the patient was pregnant with an estimated date of delivery of 21-Dec-2007.  It was reported that the patient sought unspecified medical attention.  Laboratory evaluation revealed a positive serum pregnancy test and the patient had a fetal ultrasound (results not reported).  Follow-up information indicated that on 12-DEC-2007 the patient gave birth to an infant that weighed 7 pounds 12 ounces.  The infant was healthy and normal.  It was reported that the mother experienced "mild pre-eclampsia and blood pressure issues."  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Herpes virus infection, Streptococcal identification test positive, Ultrasound scan
Clinical narrative: Initial and follow up information has been received from a medical assistant via the pregnancy registry for GARDASIL, concerning a 22 year old female with allergies to amoxicillin, CECLOR and erythromycin, who on 25-JAN-2007 was vaccinated with a single, first dose of GARDASIL at another clinic (lot #654510/0962F).  Concomitant therapy included an unspecified prenatal vitamin and ferrous sulfate (unspecified).  Subsequently the patient became pregnant (LMP 09-JAN-2007, EDD 16-OCT-2007).  On 19-MAR-2007 an ultrasound showed that the pregnancy was 10.8 weeks along, her EDD was 08-OCT-2007, and it showed the "size and dates" (not further specified).  As of 25-APR-2007 the patient had not experienced any side effects.  Follow up information from the MA, confirmed that on 08-OCT-2007, an 8 pound 9 ounce, 20 inch long, normal female infant (Apgar score 8.7) was born, at 39 weeks after the date of LMP.  The pregnancy and delivery had been without complications.  Follow-up information was received from a health professional.  The baby had a head circumference of 31.5.  The patient was Group B streptococcus positive.  The patient had herpes in the last 3 weeks of pregnancy and was treated with acyclovir.  The patient also had UNISOM for allergies and PRILOSEC for heartburn.  Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gestational diabetes, Pregnancy test positive
Clinical narrative: Information has been received from a physician for the Pregnancy Registry for GARDASIL concerning an approximately 23 year old female with a history of seizures who on 16-JAN-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 655619/1427F).  Concomitant therapy included YASMIN and CARBATROL.  Subsequently the patient was found to be about 9 weeks pregnant at the time of the vaccination and sought unspecified medical attention.  A pregnancy test was performed which was positive (not further specified).  Follow-up information was received from the physician who reported that the mother developed gestational diabetes and went on to deliver a healthy, normal infant at term.  No further information was available.  Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck pregnancy registry, from a registered nurse, concerning a 31 year old female patient who in August 2006 and October 2006 was vaccinated with the first and second doses of GARDASIL, respectively.  On 07-JAN-2007 the nurse reported that the "patient has become pregnant during the 3-dose series."  The nurse added that "no adverse reactions have been reported for this patient."  Date of the last menstrual period was 7-JAN-2007 and the patient delivered on 07-OCT-2007 at 39 weeks estimated gestational age.  She had an uncomplicated vaginal birth and a healthy female infant.  The patient sought unspecified medical attention.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pain, Pregnancy, Vomiting
Clinical narrative: Initial and follow-up information has been received from a physician and a nurse through a Merck Pregnancy Registry concerning a 19 year old female patient, who was vaccinated by injection with the first, 0.5 ml dose of GARDASIL.  After a couple of weeks the patient developed vomiting pains and was rushed to the Emergency Room.  The patient was tested and diagnosed as being pregnant.  The patient sought medical attention.  Follow-up information indicated that the patient vaginally delivered a healthy, normal female at 39 weeks on an unspecified date.  The infant weighed 6 pounds 14 ounces.  The baby experienced some jaundice as a newborn.  It was reported that the mother and baby were doing well.  Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 60 year old female consumer who on 20-MAR-2008 was vaccinated with 1 dose of ZOSTAVAX.  The next day (21-MAR-2008) the patient presented with a little raised rash at the injection site.  Unspecified medical attention was sought.  At the time of the report the patent had not recovered.  There was no product quality complaint involved.  Follow-up information has been received from a registered nurse concerning this 61 year old (also reported as 60 year old) female consumer with sulfonamide and erythromycin allergies who on 19-MAR-2008 at 07:53 was vaccinated SQ in the left arm with a first dose of ZOSTAVAX (lot # "1857U").  There was no illness at the time of vaccination.  Subsequently, on 21-MAR-2008 the patient developed 5-6 cm erythema around the injection site and a group of vesicles right at the injection site.  On an unspecified date the patient recovered.  Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Brachial plexopathy, Electromyogram abnormal, Electromyogram normal, Muscular weakness
Clinical narrative: Information has been received from a physician concerning a 71 year old male consumer who on 16-NOV-2007 was vaccinated subcutaneous with ZOSTAVAX.  Concomitant therapy included "some cholesterol medications".  Subsequently, the patient experienced "radicular pain on the side where he received the vaccine."  On 23-NOV-2007 the patient was "back in the clinic" with this pain.  He was "eventually" diagnosed with brachial plexopathy after further testing.  At the time of the report the patient was still weak in his arm, but was recovering.  There was no product quality complaint involved.  Follow-up information has been received from the physician concerning this 71 year old male consumer with sulfonamide and neomycin allergies who on 16-NOV-2007 was vaccinated SQ in the left arm with a first dose of ZOSTAVAX (lot # 658838/1412U).  Concomitant vaccination included an eighth dose of FLUZONE (lot #U2457AA) IM in the left arm.  There was no illness at the time of vaccination.  On 19-NOV-2007 the patient was assessed by a neurologist and diagnosed with brachial plexopathy.  An EMG in December 2007 confirmed the diagnosis.  In March 2008 the patient recovered from left brachial plexopathy according to his EMG results.  It was also reported that the patient had manifested left shoulder abductor weakness.  At the time of the report the patient was improving.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 60 year old female who in March 2008, was vaccinated with a dose of ZOSTAVAX subcutaneously.  Subsequently the patient experienced tingling in her right arm for about 2 weeks.  Unspecified medical attention was sought.  The patient was recovering.  No product quality complaint.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Peripheral coldness
Clinical narrative: Information has been received from a 70 year old male consumer with "thyroid problems" and a VICODIN allergy who on 12-JUL-2007 was vaccinated with ZOSTAVAX.  Concomitant therapy included levothyroxine Na.  On approximately 19-JUL-2007, within a week after receiving vaccination, the patient experienced numbness on his feet.  Medical attention was sought, the patient saw the physician.  There were no lab studies performed.  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  Follow-up information from the patient indicated that his feet are still numb and cold, and he desperately needed some relief.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Thyroid disorder
Clinical narrative: Information has been received from a consumer concerning her granddaughter who was vaccinated on an unspecified date with GARDASIL (lot# not reported).  subsequently the patient experienced an elevated thyroid and the grandmother wanted to know if this was related to GARDASIL.  No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning "no more than ten patients" who were vaccinated with GARDASIL (lot#, route and dose not reported), which was inadvertently stored in the freezer for 2 weeks.  The medical assistant reported that no adverse event was reported.  No additional information was provided.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 22 year old female who on 12-MAY-2008 was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly.  The nurse stated that on 02-JUN-2008, the patient called the office stating that her arm had been painful at the injection site for the past 3 weeks.  At the time of the report the patient was not recovered.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Hot flush
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with allergies to penicillin and sulfa antibiotics, who on 27-NOV-2007 was vaccinated with the first dose of GARDASIL 0.5 ml intramuscularly (lot# 658560/1062U).  There was no concomitant medication.  The nurse reported that on 15-JAN-2008, the patient received the second dose of GARDASIL 0.5 ml intramuscularly (lot# 658560/1062U).  The nurse noted that in March 2008, the patient developed red flushing on her cheeks, nose and forehead and experienced hot flashes.  The patient sought unspecified medical attention.  The nurse reported that the patient recovered (date unspecified).  No other information was available.  Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 35 year old female patient with no medical history reported, who on approximately 01-APR-2008, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL.  On 19-MAY-2008, "approximately two weeks ago," the patient developed redness, swelling, pain and heat at the injection site after receiving her second dose.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus antibody negative, Fatigue, Full blood count normal, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a physician concerning a 17 year old female with obesity, asthma, depression and allergy to amoxicillin who on 22-APR-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL.  There was no concomitant medication.  On 02-MAY-2008 the patient experienced fatigue.  The patient sought medical attention in the emergency room for evaluation but was not admitted.  Laboratory studies performed included erythrocyte sedimentation rate, mononucleosis serological test, complete blood count and all results were negative.  At the time of the report, the patient was recovering.  The physician stated she does not believe that the fatigue and the vaccination with GARDASIL are associated.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Oedema peripheral, Pruritus, Pyrexia, Skin papilloma
Clinical narrative: Information has been received from a certified nurse midwife concerning a 20 year old female with sulfonamide allergy and no pertinent medical history who on 08-MAY-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL (Lot# 660387/1967U) in the left deltoid. Concomitant therapy included hormonal contraceptives (unspecified).  On 11-MAY-2008, "3 days later" the patient developed about 16 warts in total all over the back of her hands.  The patient's hands started to swell, she was very itchy and had a low grade fever.  The patient sought medical attention in the emergency room but was not admitted to the hospital.  The patient was seen by the dermatologist and had a biopsy (awaiting results).  At the time of the report, the patient's outcome was not recovered.  Additional information has been requested.