chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Auricular swelling, Dyspnoea, Eye pruritus, Eye swelling, Stomach discomfort
Clinical narrative: Upset stomach, difficulty breathing through nose, puffy, itchy eyes, hives, swollen eyes and ears - Benadryl and Zyrtec.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Upset stomach, difficulty breathing through nose, puffy, itchy eyes, hives, swollen eyes and ears - Benadryl and Zyrtec.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Vomiting
Clinical narrative: Headache - slight - only for few hours vomited 2 times same evening
Age: 0.6
Sex: F
Vaccine: MMR, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: administered wrong vaccine to patient - MMR instead of DTaP. No reaction has occurred.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pyrexia, Rash
Clinical narrative: Right arm swelling 2 days, after getting shots. (Notified us on 10/17/08). Developed rash, fever. she talked to doctor, not too concerned. Advised her to take TYLENOL and apply ice pack.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Anger, Computerised tomogram normal, Erythema, Full blood count
Clinical narrative: Large local reaction - redness, swelling. Took BENADRYL - agitation, rage, headache, pupils unequal, low LOC.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Laboratory test, Local reaction, Loss of consciousness, Pupils unequal
Clinical narrative: Large local reaction - redness, swelling. Took BENADRYL - agitation, rage, headache, pupils unequal, low LOC.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Large local reaction - redness, swelling. Took BENADRYL - agitation, rage, headache, pupils unequal, low LOC.
Age: 27.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cough, Ocular hyperaemia, Pruritus, Throat irritation, Urticaria
Clinical narrative: Tdap and TIV given. Approx. 10 min. after had hives, red eyes, itching, cough, scratchy throat. Vital signs stable throughout. Epinephrine 1:1000 0.2 ml SQ @ 1121; BENADRYL 25 mg IV @ 1125; BENADRYL 50 mg po @ 1150. Discharged home at 1220 in stable condition.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Chest discomfort, Electrocardiogram, Feeling jittery, Oropharyngeal pain
Clinical narrative: Received TIV approx 12:30. Reports pain down arm after injection. Approx 1 1/2 - 2 hrs. Post vaccination c/o chest and throat discomfort. States feels "jittery". C/o Tinnitis. 25 mg BENEDRYL IM given. Physician diagnosed: "Anxiety and (L) arm pain post injection" D/C home stable.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Received TIV approx 12:30. Reports pain down arm after injection. Approx 1 1/2 - 2 hrs. Post vaccination c/o chest and throat discomfort. States feels "jittery". C/o Tinnitis. 25 mg BENEDRYL IM given. Physician diagnosed: "Anxiety and (L) arm pain post injection" D/C home stable.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Use of expired influenza vaccine. No c/o illness, symptoms.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: Use of expired influenza vaccine. No c/o illness, symptoms.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Expired drug administered
Clinical narrative: Use of expired influenza vaccine. No c/o illness, symptoms.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Small blisters around injection sight.
Age: 14.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Fever to 104, Headache frontal/maxillary
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Cyanosis, Postictal state, Pyrexia, Staring
Clinical narrative: Child was seen in our office 10-16-08 and received the flu vaccine that evening. Mom states that she left our office and went to Wal-Mart. As she pulled into driveway @ home, less than 2 hrs later, child was staring and lips were blue, his O2 sat was 95. Ambulance was called and child taken to ER, dx - post-ictal. With febrile illness/child had low grade fever 101.4 degrees. No wheezing.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Pt developed cellulitis at the site of injection (R upper arm).
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site streaking, Swelling
Clinical narrative: Pt c/o swelling, redness, red streaks. Call pt today 10/16/08 pt. states doing much better. No redness/swelling or streaks much better.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site warmth, Oral pruritus
Clinical narrative: Redness warmth at GARDASIL injection site - Full tongue itchy HARDPALATE - NO SOB No Wheezing
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation, Throat tightness, Vomiting
Clinical narrative: Patient received injection at about 3 pm and between 5-6 pm started getting fever, scratchy throat. Between 6-7 pm sx of throat closing and vomiting. Patient seen and treated.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Dyspnoea, Erythema, Full blood count, Laboratory test
Clinical narrative: Shortness of breath, temp of 103 degrees, left arm deltoid with edema, redness, warm to touch, ROCEPHIN IM in ER and KEFLEX 500 mg 1 po TID x 10 days, Naproxen DS 550 mg.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Shortness of breath, temp of 103 degrees, left arm deltoid with edema, redness, warm to touch, ROCEPHIN IM in ER and KEFLEX 500 mg 1 po TID x 10 days, Naproxen DS 550 mg.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pruritus, Rash, Sleep disorder
Clinical narrative: Patient - on Monday Oct 13, 2008, Rash - on Left hip - Long and narrow and then spread next day to stomach, went to MD - Tues. Pain, itching, lethargy, no sleep
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, PPV, VARCEL
Symptoms: Abscess, Induration, Pain, Skin warm, Swelling
Clinical narrative: 3 days after receiving immunizations pt. presented with (L) sterile abscess 10 cm x 10 cm, warm to touch, swollen, and painful. Also (R) indurated area 4.5cm x 5cm, both corresponding to subcutaneous location of immunizations.
Age: 21.0
Sex: U
Vaccine: TYP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Diagnosed 17 week pregnant. Has received TYPHOID 7/9/08, AVA #1 9/4/08, and SMPX 9/24/08 before pregnancy diagnosed.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Febrile convulsion
Clinical narrative: First febrile seizure transported to ED.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccines given 10/15/08, developed swelling, redness, hot to touch on left deltoid area. No streaking or signs/symptoms infection. Mother applying cold compresses giving TYLENOL, swelling decreased on 2nd day, non-tender.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Pruritus, Scratch
Clinical narrative: Client began itching/scratching her nose, behind ears and upper chest immediately (within 1 minute after injections). Requested client stay until 1:55 for monitoring. Gave IM BENADRYL 25 mg (R) deltoid at 1:15. Never developed any hives, laryngeal or oral edema. No difficulty breathing. Left facility with mother carrying her at 1:55. Advised ER if any worsening or recurrence.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthma, Condition aggravated, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness/swelling/warmth at injection site about 20 degrees after vaccine. Also asthma flare - mild.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Injection site mass, Medical device complication, Ultrasound scan
Clinical narrative: Lt thigh with small lump-palpable. No open skin incident: syringe hub broke with injection at needle intact per ma; needle was completely out of skin.  Mom concerned possibly lump D/T needle broke inside skin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Pt seen 9/25/08 in clinic, LF thigh with erythema 15 1/2 cm length 5cm width. Advised home care measures with Benadryl for itching. 9-29-08pt seen urgent care, tx: antibiotic.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local reaction, Pruritus
Clinical narrative: Local erythema, itching, induration.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ultrasound scan, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 29 year old white female with hypothyroidism and migraine headache and no previous pregnancy. In April-2007, the first ultrasound was performed for fetal survey. On 20-APR-2007, serum alpha-fetoprotein test was performed for screening and the result was normal. On 04-JUN-2007, the second ultrasound was performed for fetal survey. On 06-AUG-2007 the patient was vaccinated with a dose of GARDASIL when she was 29 weeks pregnant. The patient received the vaccine in error and was supposed to receive RHOGAM. Concomitant therapy included SYNTHROID and prenatal vitamins. On 16-AUG-2007 and 27-SEP-2007, separate ultrasound was performed. On 01-NOV-2007 the patient delivered a health normal baby boy at 41.2 weeks gestation. The weight of the baby was 8.0 pounds; the length was 21 inches; the Apgar score was 9/9. There was no congenital anomaly or complication with the baby. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from Merck pregnancy registry from a health professional and a 25 year old female with 1 previous pregnancy with full term delivery who on 27-JUL-2007 was vaccinated with a first dose of GARDASIL. There was no concomitant medications at the time of vaccination. Subsequently, she learned she was pregnant. The patient's last menstrual period was 20-JUL-2007 and estimated of delivery was 25-APR-2008. Ultrasound on 17-SEP-2007 and 18-DEC-2007 were within normal limits. Unspecified medical attention was sought. On 09-APR-2008, 37 weeks from LMP, the patient delivered vaginally a normal female (weight 7 pounds 15 ounces and length 20.5 inches). Follow up information reported that on 12-APR-2008, the newborn was seen in the office for jaundice. The physician reported that the newborn female was a healthy appearing, alert, normally nourished, developmentally normal, well hydrated child in no acute distress. The infant had skin symptoms of jaundice. Bilirubin levels were ordered and were as follows: Neonatal bilirubin was high at 12.3 and indirect bilirubin was high at 12. On 13-APR-2008 the physician reported that the patient had jaundice to the hips. Bilirubin levels were ordered and were as follows: Neonatal Bilirubin was high at 13.3 and Indirect Bilirubin was high at 12.9. On 14-APR-2008 the patient was evaluated at the office, and the child's mother stated "she looks less yellow today." The physician reported the patients status as improved. The child was to return to the clinic to follow-up in 2 weeks. The newborn was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) on 09-APR-2008 at birth. (WAES0809USA03006). Other medication used during this pregnancy included pre-natal vitamins from 13-SEP-2008 to 09-APR-2008. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chlamydial infection, Drug exposure during pregnancy, Foetal disorder, Papilloma viral infection, Pregnancy test positive
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant, for the Pregnancy Registry for GARDASIL concerning a 19 year old female with a history of heart murmur and 1 previous pregnancy and 1 full term delivery who on 04-SEP-2007 was vaccinated intramuscularly with the first dose of GARDASIL during the first trimester of pregnancy. Concomitant therapy included prenatal vitamins and iron tablets. The patient sought unspecified medical attention in the physician's office. On 13-SEP-2007 routine ultrasound was performed and the result was normal. Follow-up information was received that during pregnancy, the patient developed papilloma viral infection and Chlamydia infection. On 27-January-2008, the patient was placed on ZITHROMAX, 1 gram, 1 dose for the treatment of Chlamydia infection. The outcome was unknown. During labor/delivery, the baby developed umbilical cord around neck. On 05-MAR-2008 the patient delivered a full-term, normal and healthy baby boy with no congenital anomalies. The weight of the baby was 7.4 pounds and the Apgar score was 9/9. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant, for the Pregnancy Registry for GARDASIL concerning a 19 year old female with a history of heart murmur and 1 previous pregnancy and 1 full term delivery who on 04-SEP-2007 was vaccinated intramuscularly with the first dose of GARDASIL during the first trimester of pregnancy. Concomitant therapy included prenatal vitamins and iron tablets. The patient sought unspecified medical attention in the physician's office. On 13-SEP-2007 routine ultrasound was performed and the result was normal. Follow-up information was received that during pregnancy, the patient developed papilloma viral infection and Chlamydia infection. On 27-January-2008, the patient was placed on ZITHROMAX, 1 gram, 1 dose for the treatment of Chlamydia infection. The outcome was unknown. During labor/delivery, the baby developed umbilical cord around neck. On 05-MAR-2008 the patient delivered a full-term, normal and healthy baby boy with no congenital anomalies. The weight of the baby was 7.4 pounds and the Apgar score was 9/9. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received through the Merck Pregnancy Registry through a health professional concerning an 18 year old female with a history of attention deficit disorder, and mood swings, who on 27-NOV-2007 was intramuscularly vaccinated with her first dose of GARDASIL (Lot # 659437/1266U) and was subsequently determined to be pregnant (LMP=12Nov2007). Urine pregnancy test was positive. Concomitant therapy included CONCERTA, NORDETTE, LEVORA, and LEXAPRO. The patient sought medical attention during an exam in the office. No problems were reported. Follow-up information was received on 22-SEP-2008 from a registered nurse concerning an 18 year old white female who smoked daily before pregnancy and quit tobacco use when pregnant. Other medications used during pregnancy included LEXAPRO, 20 mg, once a day for the treatment of mood swings (stopped a 5 weeks pregnant), CONCERTA, 72 mg, once a day for the treatment of Attention deficit disorder (stopped at 5 weeks pregnant) and prenatal vitamin daily PO. On 22-AUG-2008, at 39 weeks from her LMP, the patient delivered a normal female baby weighting 7 pounds, 12 ounces. The baby's length was 19 inches and head circumference was 34 cm. The baby developed an elevated white blood cell count at birth and was treated intravenously with antibiotics for 10 days. The outcome of the baby was not reported. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Chlamydial infection, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a mother and a licensed practical nurse for the Merck Pregnancy Registry for GARDASIL concerning her 17 year old daughter with no previous pregnancies who on approximately 07-JAN-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL. The mother was calling to report that her daughter was pregnant after receiving the vaccine. Therapy was discontinued. The patient's mother reported that "they had no physician information because they have not found an OB/GYN in their area." The patient's mother advised that "once a doctor has been found they would call with the information." Medical attention was not sought. The patient's mother requested prescribing information. No product quality complaint was involved. On 29-JAN-2008 the patient was placed on therapy with ZITHROMAX (250mg once) for the treatment of chlamydia. Other medications taken during pregnancy included ZOFRAN and pre-natal vitamins. On 29-MAY-2008, the ultrasound was performed for rule out abruption and the result was normal. On 05-MAR-2008 the serum alpha fetoprotein test was performed as routine screen with negative result. On 09-AUG-2008 the patient delivered a normal female baby weighing 7 pounds 6 ounces at 38.5 weeks. There were no complications during pregnancy and labor/delivery. There were no congenital anomalies, other complications or abnormalities. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein, Antepartum haemorrhage, Drug exposure during pregnancy, Laboratory test, Obstetrical procedure
Clinical narrative: Information has been received through the Merck pregnancy registry from a health professional concerning a 21 year old female who was vaccinated with her first dose of GARDASIL and it was subsequently discovered that the patient was pregnant. The patient's LMP=16-Nov-2007. Follow-up information has been received from a registered nurse. The patient experienced early pregnancy bleeding. The reporter was not aware of any other information that would inform the outcome of this pregnancy. Medications used during pregnancy included pre-natal vitamins (unspecified). There were no other complaints during pregnancy and labor/delivery. The prenatal labs, obstetrical procedure, serum alpha-fetoprotein test and ultrasound were performed. On 12-AUG-2008 the patient delivered a normal, health male baby weighing 7 pounds 6 ounces length 19.5 inch at 38 weeks with Apgar score "4/9/9." There were no congenital anomalies and no other complaints or abnormalities. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received through the Merck pregnancy registry from a health professional concerning a 21 year old female who was vaccinated with her first dose of GARDASIL and it was subsequently discovered that the patient was pregnant. The patient's LMP=16-Nov-2007. Follow-up information has been received from a registered nurse. The patient experienced early pregnancy bleeding. The reporter was not aware of any other information that would inform the outcome of this pregnancy. Medications used during pregnancy included pre-natal vitamins (unspecified). There were no other complaints during pregnancy and labor/delivery. The prenatal labs, obstetrical procedure, serum alpha-fetoprotein test and ultrasound were performed. On 12-AUG-2008 the patient delivered a normal, health male baby weighing 7 pounds 6 ounces length 19.5 inch at 38 weeks with Apgar score "4/9/9." There were no congenital anomalies and no other complaints or abnormalities. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Foetal disorder, Premature labour, Ultrasound scan
Clinical narrative: Initial information has been received from a health professional and follow-up information was received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 20 year old white female with depression, sciatica, drug hypersensitivity to PHENERGAN and amoxicillin and a history of 1 previous pregnancy (1 full-term delivery), cervical dysplasia, right ovarian cystectomy (2006), and loop electrosurgical excision of transformation zone procedure (LEETZ, in 2007). On 07-FEB-2008 the patient was vaccinated with the first dose GARDASIL (lot# not provided). On 13-FEB-2008 the patient had a positive blood test for pregnancy (LMP 15-JAN-2008) and an ultrasound on 27-FEB-2008 (IUP 8w5d). On approximately March 2008, the patient developed GARDNERELLA vaginitis. On 25-MAR-2008  the patient was placed on therapy with PROZAC, 20 mg, once a day, orally, for the treatment of depression and FLAGYL, 500 mg, twice a day, orally, for the treatment of GARDNERELLA vaginitis. On 30-JUN-2008 therapy with PROZAC was discontinued. On 01-JUL-2008 therapy with FLAGYL was discontinued. The outcome of GARDNERELLA vaginitis was unknown. On approximately 28-JUL-2008, the patient developed preterm labor at 30 weeks gestation. On 28-JUL-2008 the patient was placed on CELESTONE, 12 mg, every 12 hours, intramuscularly and magnesium sulfate, 2 gram every hour for the treatment of preterm labor. On 29-JUL-2008 therapy with CELESTONE was discontinued. On 30-JUL-2008 therapy with magnesium sulfate was discontinued and the patient was placed on terbutaline sulfate, 2.5 mg, every 4 hours, orally, for the treatment of preterm labor. On 11-AUG-2008 therapy with terbutaline sulfate was discontinued and the patient was placed on an unspecified medication, 10 mg, every 6 hours, orally, for the treatment of preterm labor. On the same day, the unspecified medication was discontinued. On 09-SEP-2008 the patient delivered a 7 pounds 6 ounces normal boy. The baby was diagnosed with sleep apnea and gastric reflux. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginitis gardnerella
Clinical narrative: Initial information has been received from a health professional and follow-up information was received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 20 year old white female with depression, sciatica, drug hypersensitivity to PHENERGAN and amoxicillin and a history of 1 previous pregnancy (1 full-term delivery), cervical dysplasia, right ovarian cystectomy (2006), and loop electrosurgical excision of transformation zone procedure (LEETZ, in 2007). On 07-FEB-2008 the patient was vaccinated with the first dose GARDASIL (lot# not provided). On 13-FEB-2008 the patient had a positive blood test for pregnancy (LMP 15-JAN-2008) and an ultrasound on 27-FEB-2008 (IUP 8w5d). On approximately March 2008, the patient developed GARDNERELLA vaginitis. On 25-MAR-2008  the patient was placed on therapy with PROZAC, 20 mg, once a day, orally, for the treatment of depression and FLAGYL, 500 mg, twice a day, orally, for the treatment of GARDNERELLA vaginitis. On 30-JUN-2008 therapy with PROZAC was discontinued. On 01-JUL-2008 therapy with FLAGYL was discontinued. The outcome of GARDNERELLA vaginitis was unknown. On approximately 28-JUL-2008, the patient developed preterm labor at 30 weeks gestation. On 28-JUL-2008 the patient was placed on CELESTONE, 12 mg, every 12 hours, intramuscularly and magnesium sulfate, 2 gram every hour for the treatment of preterm labor. On 29-JUL-2008 therapy with CELESTONE was discontinued. On 30-JUL-2008 therapy with magnesium sulfate was discontinued and the patient was placed on terbutaline sulfate, 2.5 mg, every 4 hours, orally, for the treatment of preterm labor. On 11-AUG-2008 therapy with terbutaline sulfate was discontinued and the patient was placed on an unspecified medication, 10 mg, every 6 hours, orally, for the treatment of preterm labor. On the same day, the unspecified medication was discontinued. On 09-SEP-2008 the patient delivered a 7 pounds 6 ounces normal boy. The baby was diagnosed with sleep apnea and gastric reflux. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Premature labour, Ultrasound abdomen
Clinical narrative: Information has been received from a physician and a medical assistant for the Pregnancy Registry for GARDASIL concerning a 16 year old female with anemia and a history of 0 pregnancies who in June 2007, was IM vaccinated with GARDASIL.  Medications taken during pregnancy included pre-natal vitamins (unspecified).  The patient became pregnant sometime during the vaccination series.  On 06-MAR-2008 the maternal serum alpha-fetoprotein test (MSAFP) was performed with the negative result.  A positive ultrasound for pregnancy was performed on 13-Mar-2008.  It is suspected that the patient's LMP is 23-Oct-2007.  The patient sought unspecified medical treatment with an office visit.  On 30-May-2008, the patient threatened premature labor.  On that same day, she was placed on therapy with terbutaline sulfate (5 mg Q4H until 36 weeks) and KEFLEX (500 MG QID).  On 10-JUL-2008 the patient delivered a normal female baby with apgar score 8/9.  There were no complications during labor/delivery.  There were no congenital anomalies abnormalities or complications.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Apgar score normal, Drug exposure during pregnancy, Gastrooesophageal reflux disease, Urine human chorionic gonadotropin positive
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/14/2008: 1/7/2009. Information has been received from a nurse practitioner concerning a 21 old pregnant female with a history of 2 pregnancies (1 miscarriage and 1 to full term) who on 25-JAN-2008 was vaccinated IM with the first dose of GARDASIL (lot # 659437/1266U). A urine pregnancy test was performed yielding positive results. The last menstrual period was reported as 15-JAN-2008. Nurse practitioner reported she wishes to register the patient for pregnancy registry. Follow-up information was received from a nurse practitioner concerning the patient who was a smoker who in June 2008 developed gastrooesophageal reflux disease, and in September 2008 developed anemia. The patient delivered a normal, health male baby weighing 7 pounds 15 ounces on 14-SEP-2008 (weeks from LMP: 38.4 weeks). Length: 21.5 inches. APGAR score: 8/9. Head circumference: 13.5 centimeters. There were no congenital anomalies and no other complaints or abnormalities. No complication during pregnancy and labor/delivery. No diagnostic test and infections or illnesses during pregnancy. PREVACID and REPLIVA were used during this pregnancy to treat the gastroesophageal reflux disease and anemia, respectively. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Nausea
Clinical narrative: Initial and follow up information has been received from a nurse practitioner through the Merck pregnancy registry concerning an 18 year old black female with rhinitis allergic and no significant past medical history and no other concurrent medical conditions, who on 10-JAN-2008 was vaccinated with the first dose of GARDASIL (lot# 659653/1448U). On 05-MAR-2008, the patient was vaccinated with the second dose of GARDASIL  (lot 655655/1486U). Concomitant therapy included prenatal vitamins. The patient became pregnant. The last menstrual period was 20-FEB-2008. The estimated due date is 27-NOV-2008. On 30-MAY-2008, the patient developed nausea. She was treated with PHENERGAN. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ultrasound scan, Vomiting in pregnancy
Clinical narrative: Initial and follow-up information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 21 year old black female with a history of 2 previous pregnancies, 1 full term delivery in 2005, and 1 elective termination, and no defects or complications in previous pregnancies, who on approximately 23-JAN-2007 was vaccinated with GARDASIL (lot # not reported) 0.5 mL IM. There was no concomitant medication. On 20-MAR-2008 the patient was vaccinated with a second dose of GARDASIL (Lot# 659962/1740U). The patient's last menstrual period was 08-MAR-2008, her estimated conception date was 22-MAR-2008, and her estimated delivery date was 13-DEC-2008. In follow up information was reported that on an unspecified date, the patient started prenatal vitamins, 1 dose, every day for pregnancy. On 12-MAY-2008, the patient started TERAZOL at bed time, 3 doses, for morning sickness. It was also reported that on 22-JUN-2008, a maternal serum alpha-fetoprotein test performed for routine, revealed negative results. On 30-JUN-2008 an ultrasound performed, to rule out any anomaly, with result 16 5/7 weeks. On 25-JUL-2008, the patient started PROMETHAZINE, 25 mg, every six hours, as needed, for morning sickness. Follow-up information indicated that the patient had left the practice and was being cared for by another health care professional office. Follow-up information was received which reported that the patient was no longer followed in physician's office. This is one of two reports from the same source.  Follow-up information was received which reported that the patient was no longer followed in physician's office. This is one of two reports from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Facial palsy, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning an 11 year old female with no known pertinent medical history or drug reactions/allergies who on 07-JUL-2008 was vaccinated with a first dose of GARDASIL (lot# 660393/0067X) 0.5 mL IM. Concomitant therapy included a dose of ADACEL received on 07-JUL-2008. On 01-SEP-2008 the patient developed a BELL'S palsy. She has facial drooping on her right side. A magnetic resonance imaging was performed with a negative result. The patient was treated with acyclovir and prednisone. The patient was recovering from BELL'S palsy. The patient sought medical attention in the office. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician assistant concerning an approximately 20 year old female who was vaccinated the second dose of GARADSIL. A few days post the second dose the patient broke out in a rash all over her body. The patient sought medical attention. Treatment was BENADRYL, the patient recovered. The physician assistant indicated the patient would not be completing the vaccine series. This is one of several reports from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Metabolic function test normal, Periorbital oedema, Stomatitis
Clinical narrative: Information has been received from a health professional concerning a 22 year old female who on the evening of 31-AUG-2008 was vaccinated with the second dose of GARDASIL, IM  into left deltoid. The patient had been treated (06-AUG-2008) for a URI with Z-PAK. The patient awoke in AM with periorbital oedema and mouth sores on 01-SEP-2008 (also reported as 03-SEP-2008, 3 days post injection). The patient was treated with famotidine (MSD) and BENADRYL. The patient had a appointment of eye doctor and allergist. A CBC and BMP were within normal limits. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Stomatitis, Urticaria
Clinical narrative: Information has been received from a patient's mother via medical assistant who reported that her 20 year old daughter with no pertinent medical history or no drug allergies who on 06-AUG-2008 was vaccinated with the first dose of GARDASIL (lot # 660393/0067X). Concomitant therapy included hormonal contraceptives (unspecified) (oral contraceptives). About two weeks after vaccination on approximately 20-AUG-2008 the patient developed rash, hives over her face and sores in her mouth. The patient's rash and hives over her face and sores in her mouth persisted. Medical attention was sought via calling office. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Feeling hot, No reaction on previous exposure to drug, Pain
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 03-APR-2008 was vaccinated with the first dose of GARDASIL well tolerated. On 03-JUN-2008, the patient was vaccinated with the second dose of GARDASIL well tolerate. On 09-SEP-2008 the patient was vaccinated with the third dose of GARDASIL. Approximately 6 to 8 hours after the third dose the patient developed chills, aches and felt warm but never really took her temperature. The patient was advised how to self-medicate for the chills and aches and there had been no other adverse events reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Information has been received from a nurse concerning a 11 year old female who on 15-SEP-2008 at about 1530 was vaccinated with the first dose of GARDASIL (lot # 660553/0070X). Concomitant therapy included meningococcal vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. About 2 min after vaccination, the patient said she felt dizzy, became pale , and fainted into mother's arms. The patient was placed on exam table with feet elevated and she spontaneously revived. The events lasted only minutes. The patient was given water to drink. No hospitalization required. The reporter spoke with mother at home and patient remained fine at this time. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Computerised tomogram normal, Rash
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who in the Spring of 2008 was vaccinated with the third dose of GARDASIL. The physician reported that about one and a half months after the 3rd dose of GARDASIL, the patient had a severe abdominal pain. The patient also developed a mild rash on one side of the hips that radiated to the knees. The patient was seen by both her primary physician and gynecologist. On an unspecified date, the patient had a CT scan that was negative. The symptoms were diagnosed as idiopathic. Outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a female who "in the past few weeks," was vaccinated with a dose of GARDASIL. "Last Week," on approximately 09-SEP-2008 the patient experienced a migraine headache. On an unknown date, the patient recovered from migraine headache. The patient sought medical attention by phone. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history or allergies who on 04-JUN-2008 and 27-AUG-2008 was vaccinated intramuscularly with her 0.5 mL first and second doses of GARDASIL (lot #660391/0063X, 660557/0072X), respectively. There was no concomitant medication. On 29-AUG-2008 the patient developed a small bump in her right axilla. Medical attention was sought via call by the patient's mother. No laboratory or diagnostics tests were performed. The bump resolved without treatment within 12 hours. On 04-SEP-2008 the patient developed a large bump in her left axilla which resolved without treatment in 2 days. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning an 18 year old female who in May 2008, was vaccinated with her first dose of GARDASIL 0.5 mL, IM. In approximately May 2008, after receiving the vaccination, the patient experienced lymphadenopathy. The patient called the physician in August 2008, about 10 days before her schedule appointment to say her lymph nodes were swollen. The physician said to wait the 10 days and then come in for her second dose. She come in 10 days after her call but was still sick so the second dose was not given. The physician "ran a bunch of testing, including bloodwork, and ruled out mononucleosis." Patient came on 02-SEP-2008 for a follow-up, but the physician still has to send her for a biopsy. Additional information has been requested.  On 03-Nov-2008, Dr reported that the patient was seen by Infectious Disease specialist, and was diagnosed  with mononucleosis. The patient's status was reported as recovered.
Age: 16.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 11-SEP-2008, was vaccinated with her first dose of GARDASIL. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On 12-SEP-2008, the day after vaccination the patient experienced fever, sore throat and headache. The parent of patient called office. At the time of reporting, patient's fever, sore throat and headache persisted. Patient will be seen in the office today. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue, Haematology test
Clinical narrative: Information has been received from a physician concerning a female who in March 2008, was vaccinated with the first dose of GARDASIL and on 05-JUN-2008, received the second dose of GARDASIL. There was no concomitant medication. When she came back for her second dose on 05-JUN-2008, the patient experienced fatigue and joint pain. She still received her second dose and was also told to see a rheumatologist. The rheumatologist told the patient it could be fibromyalgia or rheumatoid arthritis. The patient was told to follow-up with the physician on 28-JUL-2008, however the patient never came back, but rather called the office recently and stated that she saw on the news that GARDASIL caused arthritis. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a 11 year old female who was vaccinated with the first dose of GARDASIL and had an anaphylactic reaction. The patient was reported to be recovered. The physician does not plan to continue to vaccination series. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a Physician's Assistant concerning a female patient who was vaccinated with GARDASIL (lot no., route, injection site not reported). A couple minutes later the patient fainted. Unspecified medical attention was required. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who in May 2008, was vaccinated with the second dose of GARDASIL. Subsequently, in May 2008, the patient experienced nausea, fever and back pain. Subsequently, the patient recovered from nausea, fever and back pain. The patient contacted a physician. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 25 year old female who on 14-MAR-2008 was vaccinated IM with her first dose of GARDASIL and post vaccination, unknown when, the patient developed numbness of the hands and feet, which lasted for a couple of days. The patient vaccinated IM with her second dose of GARDASIL on 14-MAY-2008 and post vaccination developed numbness of hands and feet which lasted for a couple of days. Subsequently, the patient recovered. The patient sought medical attention and the nurse called her. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Nausea, Ultrasound scan normal, Urinary tract infection
Clinical narrative: Information has been received from a health professional for the Pregnancy Registry for GARDASIL, concerning an 21 year old Caucasian female with a history of 4 previous pregnancies and 2 live births and one spontaneous abortion at 12 weeks from LMP who on 28-APR-2008 was vaccinated with a second dose of GARDASIL (lot #658282/1263U). The patient's last menstrual period was 10-MAR-2008 and estimated delivery date is 15-DEC-2008. On 16-MAY-2008 and 17-JUL-2008 the patient underwent ultrasound and the result indicated within normal limits. On 06-AUG-2008 maternal serum alpha-fetoprotein screening was performed and the result was negative. Subsequently, on an unspecified date in June 2008 the patient experienced nausea and was treated with ZOFRAN 4 mg PRN. No out come was reported. Also, on an unspecified date in September 2008, the patient developed a UTI and was treated with MACRODANTIN 100 TID. No outcome was reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a healthcare worker concerning an 18 year old female with no pertinent medical history or allergies who on 12-SEP-2008 was vaccinated intramuscularly with a 0.5 mL fourth dose of GARDASIL (lot #661530/0575X). The dates of administration and the lot numbers for the previous 3 doses of GARDASIL were unknown. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently the patient experienced arm pain, in an unspecified arm. The patient was seen at the office, no laboratory or diagnostics tests were performed. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Headache, Laboratory test, Lethargy
Clinical narrative: Information has been received from a physician concerning a 14 year old female with exertional asthma and no allergies who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL, IM 0.5 mL (lot # 659657/1487U). On 25-AUG-2008 the patient was vaccinated with the second dose of GARDASIL, IM 0.5 mL (lot # 660391/0063X). There was no concomitant medication. On 25-AUG-2008 the patient experienced headaches and lethargy since she received the second dose. The patient sought medical attention at the office. The patient's headache and lethargy persisted. The computed axial tomography, neurological exam and blood work were performed with no results provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL. The patient experienced headache after vaccination. On an unspecified date the patient recovered from headache. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL. The patient developed warts on hands after vaccination. The outcome of the patient was unknown. This is one of several reports from the same source. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Visual impairment
Clinical narrative: Information has been received from a nurse concerning an 11 year old female with no pertinent medical history who on 16-JUL-2008 was vaccinated with the first dose of GARDASIL. On 16-JUL-2008 the patient experienced dizzy, sweaty and her vision darkened right after injection. The patient sat down for a few minutes and the symptoms went away. The patient recovered from dizzy, sweaty and vision darkened. The patient sought medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a mother and a certified medical assistant concerning the development of a rash by a twin sister following vaccination. A 18 year old female who on 16-JUL-2008 was vaccinated with GARDASIL. Concomitant therapy included TRI-SPRINTEC Birth Control and CLARITINE. On approximately 06-AUG-2008, 3 to 4 weeks after vaccination, the patient experienced a rash. Patient's rash is currently resolved. Her rash was described as similar to her twin sister's (WAES 0809USA01996) Additional information has been requested. This is one of several reports received from the same source.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Blood human chorionic gonadotropin negative, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a patient's mother, an employee at the physician's office, concerning her 20 year old daughter who on 07-APR-2008, last day of her menstrual period, was first vaccinated with GARDASIL (dose was unspecified and route was injection). Concomitant therapy included NUVARING for birth control. When NUVARING was discontinued the patient still continued to have her menstrual periods. Subsequently the patient experienced amenorrhea since then. The following dose of GARDASIL (MSD) was not reintroduced. On an unspecified date the patient took pregnancy test via blood and urine and all tests were negative. The patient sought medical attention. At the time of report the patient's amenorrhea persisted. Patient didn't have medical history and drug allergies. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hallucination, Pyrexia, Tremor
Clinical narrative: Information has been received from a nurse concerning a 11 year old female who on 15-MAY-2008 was vaccinated with the first dose of GARDASIL IM (lot # 660391/0063X). The patient did not stay for the 15 minutes shot check, however called the office later (time unspecified) and stated that she was hallucinating, shaky and had a fever. The patient came to the office for any follow-up. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a female patient who completed the series for GARDASIL. On an unspecified date, the patient was HPV positive. The outcome of the patient was not reported. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Hair disorder
Clinical narrative: Information has been received from a licensed practical nurse concerning 2 girls who on an unspecified dates were vaccinated with an unspecified dose of GARDASIL. A patient's mother heard that they have had hair loss and hair brittleness after vaccination with GARDASIL. These 2 girls are athletes and wash their hair several times each day. Additional information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia oral
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female with allergy to horses who on 10-SEP-2008, was vaccinated with GARDASIL (lot no. 660553/0070X) 0.5 mL, IM. There was no concomitant medication. On 10-SEP-2008, about 90 minutes after vaccination, the patient experienced numbness of her tongue and roof of her mouth. Within an hours, the patient recovered without treatment. No laboratory tests were performed. The patient sought unspecified medical attention. Additional information has been requested.