chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: F
Vaccine: FLUN3, HIBV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: A non-serious, spontaneous report of FLUMIST vaccine inadvertently administered to a seven-month-old female was received from a nurse.  This case is submitted in accordance with organization's post-marketing commitment on accelerated reporting for the newly indicated population of 7 years to 59 months of age for FLUMIST.  Concomitant medications include Hib vaccination.  The patient had no known allergies.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmunes post - marketing comitment on accelerated reporting for the newly indicated population of 2 years to 56 months of age for FLUMIST.
Age: 3.0
Sex: U
Vaccine: FLUN3, HEPA
Symptoms: Condition aggravated, Oropharyngeal blistering
Clinical narrative: A non-serious spontaneous report of blisters on mouth was received from a physician's office concerning a three-year-old subsequent to FLUMIST.  This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Neither relevant medical history nor concomitant medications was reported for this patient.  The patient received FLUMIST for the first time and Hep A for the second time.  Twenty-four hours after receiving FLUMIST and Hep A, the patient developed blisters on mouth.  After the office had further discussion with the toddler's mother, it was discovered that the child has had blisters around the mouth on several different occasions and it was probably no related to vaccines.  The outcome of the adverse events was not reported.  Additional dosing with FLUMIST was not reported.  The adverse event of blisters on mouth was reported as probably not related to FLUMIST.
Sex: U
Vaccine: FLUN3
Symptoms: Asthma, Condition aggravated
Clinical narrative: A non-serious spontaneous report of asthma attack was received from a Allergist's office concerning a child subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient has a history of asthma. No concomitant medications were reported for this patient. The patient received FLUMIST for the first time. Twenty-four to forty-eight hours after receiving FLUMIST< the patient was seen in the emergency room for an asthma related event. The child was treated, stabilized and released from the emergency room. The final outcome of the adverse event was not reported. Additional dosing with FLUMIST was not reported. The causality for asthma attack to FLUMIST was not reported.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: A Non-Serious Spontaneous report of HEADACHE has been received from a consumer concerning a four-year old male patient subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 02Sep-2008. The patient's parents reported that approximately six hours after FLUMIST administration, the patient experienced headache that lasted 10-12 hours into the night. The patient was given pain relievers with no relief. The outcome of the adverse event is resolved. The event resolved in the early morning hours.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Pain in extremity, Rash, Urticaria
Clinical narrative: A non-serious spontaneous report of hives, intermittent rash, and hips and shins hurting has been received from a physician in the USA concerning a three year old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient had no known allergies and no relevant medical history.  There was no concomitant medication.  On 03-Sep-2008, The patient received FLUMIST, intranasal administration for flu immunization at approximately 11:00am.  The patient received no prior doses.   Approximately eight hours after FLUMIST administration on 03 Sep 2008,  the patient developed an intermittent rash and hives were on that "broke out" 5 times throughout that night and would come and go.  The rash and hives were on the patient's face, abdomen, and back, not on her arms or legs.  The hives were described as raised lesions the size of mosquito bites with pale centers and they itched.  The patient had no swelling, no trouble breathing, and no other symptoms.  She was treated with oral BENADRYL and seen in the office on 04-Sep-2008.  The rash and hives had improved.  The patient's mother called the physician's office on 10-Sep-2008 and reported she had stopped BENADRYL because the rash and hives went away but they subsequently came back.  She also reported the patient's hips and shins were hurting on 09-Sep-2008 but that stopped the following day.  The physician told the patient's mother  to continue oral BENADRYL because the hives could last up to 3 weeks and start TYLENOL for discomfort.  The patient recovered from the hips and shins hurting and as of the last phone call from the patient's mother to the physician on 10-Sep-2008.   The hives and intermittent rash were ongoing.  Additional information was received on 19-Sep-2008 and incorporated into the above narrative which included reporter information, vaccine information, additional events, and event outcomes.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Laboratory test normal, Mastitis
Clinical narrative: Initial and follow up information has been received from two registered nurses for the Pregnancy Registry for GARDASIL concerning a 22 year old female, with no relevant medical history, no known drug allergies and no previous pregnancies, who on 12-MAR-2007 was vaccinated IM with 0.5 ml of the first dose of GARDASIL (Lot #656049/0187U). There was no concomitant medication. The patient was currently pregnant with a LMP of 15-FEB-2007. All prenatal labs were normal. It was reported that on an unspecified date, the patient began taking prenatal vitamins. Medical attention was sought. On 17-JUL-2007, the patient had a routine ultrasound which was normal (not further specified). On 21-NOV-2007, the patient gave birth to a healthy baby girl (3510 gm; 20 in), with Apgar scores of 9 and 9. There were no congenital anomalies, complications or abnormalities. There were no complications during the pregnancy or during labor and delivery. Follow-up information was received indicated that in approximately December 2007, the patient experienced mastitis and was treated recently (unspecified). The outcome was unknown. Pediatric medical records were received, refer WAES # 0810USA00111. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood bilirubin increased, Drug exposure during pregnancy, Foetal disorder, HIV test negative, Smear cervix normal
Clinical narrative: Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from a health professional concerning a 25 year old female patient with allergic reaction to codeine, allergic reaction to antibiotics, genital herpes (onset 2006) and a history of d pelvic inflammatory disease (2005) who on 18-MAY-2007 was vaccinated IM with a first dose of GARDASIL (lot #657621/0387U). Concomitant therapy included VALTREX. The reporter mentioned that they found out that patient was pregnant one day before her second injection was due (LMP= 14-JUN-2007). The second dose of GARDASIL was not administered. Patient had cervical smear test and enzyme immunoassay HIV antibody screen laboratory tests were done. On 11-OCT-2007 the patient had a normal serum alpha fetal protein and on 26-NOV-2007 the patient had a normal ultrasound. On 09-APR-2008 (41 weeks from LMP) the patient delivered a normal male infant (weight 9 pounds, 0 ounces). Apgar score were 8 and 9. There were no congenital anomalies, complications or abnormalities. Follow-up information was received via medical records. The baby developed jaundice on 14-APR-2008. On 23-APR-2008 bilirubin test was performed the result was 14.7. On 02-MAY-2008 the baby's skin looked good. On 27-MAY-20087 the baby vomited twice. There was no fever, cough etc. The patient subsequently recovered from the jaundice and vomiting. No further information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Initial and follow up information has been received for the Pregnancy Registry for GARDASIL from a health professional concerning a 25 year old female patient with allergic reaction to codeine, allergic reaction to antibiotics, genital herpes (onset 2006) and a history of d pelvic inflammatory disease (2005) who on 18-MAY-2007 was vaccinated IM with a first dose of GARDASIL (lot #657621/0387U). Concomitant therapy included VALTREX. The reporter mentioned that they found out that patient was pregnant one day before her second injection was due (LMP= 14-JUN-2007). The second dose of GARDASIL was not administered. Patient had cervical smear test and enzyme immunoassay HIV antibody screen laboratory tests were done. On 11-OCT-2007 the patient had a normal serum alpha fetal protein and on 26-NOV-2007 the patient had a normal ultrasound. On 09-APR-2008 (41 weeks from LMP) the patient delivered a normal male infant (weight 9 pounds, 0 ounces). Apgar score were 8 and 9. There were no congenital anomalies, complications or abnormalities. Follow-up information was received via medical records. The baby developed jaundice on 14-APR-2008. On 23-APR-2008 bilirubin test was performed the result was 14.7. On 02-MAY-2008 the baby's skin looked good. On 27-MAY-20087 the baby vomited twice. There was no fever, cough etc. The patient subsequently recovered from the jaundice and vomiting. No further information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy induced hypertension, Ultrasound scan normal
Clinical narrative: Information has been received for the Merck Pregnancy Registry for GARDASIL from a 25 year old white female with crohn's disease, hypothyroidism and no drug reactions/allergies and has received the complete series for GARDASIL series. ON 13-APR-2007 the patient was vaccinated with GARDASIL (lot # unknown) injection.  Concomitant therapy included SYNTHROID and ASACOL). In May 2007 the patient received a second dose of GARDASIL. In August 2007, the patient received a third dose of GARDASIL. The patient's date of the last menstrual period was on 17-SEP-2007. Medical attention was sought. The patient reported that she conceived on 29-SEP-2007. On an unspecified date the patient also had a blood test performed. To date the patient has not experienced any adverse reactions. The estimated date of delivery is 23-JUN-2008. Follow-up information was received. ON unspecified date the patient developed gestational hypertension. Concomitant therapy also included prenatal vitamins. The patient developed a normal healthy baby boy weighing 6 pounds and 15 ounces. The apgar score was 9 and 9. the patient was 39 and 4/7 weeks for LMP. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Hypertension, Inappropriate schedule of drug administration, Ultrasound scan normal
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female with no drug allergies, who on 04-DEC-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL (Lot# 655619/1427F). There were no concomitant medications. Subsequently, the patient was 21 weeks pregnant at the time of this first dose. The patient was not experiencing any known symptoms. The patient was seen in our office. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This was the patient's first pregnancy. Follow up information was received from a nurse practitioner that the LMP of the patient was 08-JUL-2007; EDD was 15-APR-2008. Ultrasounds were done on 30-NOV-2007 and 30-JAN-2008 for size/date and review of systems which were born within normal limits. The patient took prenatal vitamins during pregnancy. She was diagnosed with hypertension later in pregnancy, she was prescribed no medications. On 09-APR-2008 (41 weeks 3 day from LMP) the patient delivered a normal, healthy female baby weighing 6lb. 4oz., length was 31.5 cm, head circumference was "49 cm". The infant was considered normal; no congenital anomalies or complications were noted. APGAR score was 8/9. The pregnancy and delivery were considered as having no complications. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Drug exposure during pregnancy, Papilloma viral infection, Pre-eclampsia, Premature labour
Clinical narrative: Information has been received through the pregnancy registry for GARDASIL from a health professional concerning a 16 year old adopted female who in November 2007 was vaccinated with the second dose of GARDASIL. Per the reporter, the patient may have been pregnant when she was given her second dose of GARDASIL (LMP=01-NOV-2007). No adverse events were reported and no further information was available. Follow up information was received which reported that the routine obstetric labs were normal and the first and second trimester metabolic panel screens were within normal limits. On 25-FEB-2008 the patient's PAP smear was abnormal: "epithelial cell, abnormality squamous: low grade squamous intraepithelial lesions. HPV changes, possible CIN1." Repeat Pap smear will be performed in 6 months. During pregnancy and labor, the patient had preeclampsia. The patient was treated with magnesium sulfate. On 16-JUl-2008 the patient delivered a baby boy at 36.4 weeks gestation. The infant's weight was 5lb 10oz. The infant was normal and no congenital abnormalities. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal, Ultrasound scan normal
Clinical narrative: Information has been received through the pregnancy registry for GARDASIL from a health professional concerning a 16 year old adopted female who in November 2007 was vaccinated with the second dose of GARDASIL. Per the reporter, the patient may have been pregnant when she was given her second dose of GARDASIL (LMP=01-NOV-2007). No adverse events were reported and no further information was available. Follow up information was received which reported that the routine obstetric labs were normal and the first and second trimester metabolic panel screens were within normal limits. On 25-FEB-2008 the patient's PAP smear was abnormal: "epithelial cell, abnormality squamous: low grade squamous intraepithelial lesions. HPV changes, possible CIN1." Repeat Pap smear will be performed in 6 months. During pregnancy and labor, the patient had preeclampsia. The patient was treated with magnesium sulfate. On 16-JUl-2008 the patient delivered a baby boy at 36.4 weeks gestation. The infant's weight was 5lb 10oz. The infant was normal and no congenital abnormalities. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.), for the pregnancy registry for GARDASIL concerning a 21 year old female with a history of anemia, Crohn's disease and abnormal Papanicolaou smears who on 28-JUN-2007 was vaccinated intramuscularly with her first dose of GARDASIL. Concomitant therapy included ORTHO-NOVUM. On 22-AUG-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL. On 12-DEC-2007 the patient was vaccinated intramuscularly with her third dose of GARDASIL. On 17-DEC-2007 the patient found out she was pregnant with a positive home pregnancy test the patient's LMP was 10-NOV-2007 (also reported as 06-NOV-2007) (due date = 13-AUG-2007). The patient was seen on 03-JAN-2008 for her first prenatal visit and an ultrasound was preformed; results showed a viable pregnancy. The patient was placed on daily prenatal vitamins. The patient has not experienced any difficulties with the pregnancy at this time. Follow-up information was received on 02-SEP-2008 from a L.P.N. indicating that on 01-JUL-2008 the patient delivered a normal female baby weighing 5 pounds, 1.1 ounces. There was no congenital abnormalities. There was no infections or illness during pregnancy. There was no complication during delivery. Other medications used during pregnancy included Celestone and Procardia. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Drug exposure during pregnancy, Nasopharyngitis, Pregnancy test positive, Premature labour
Clinical narrative: Information has been received through the Merck pregnancy registry from a health professional concerning a 16 year old female who on 09-OCT-2007 was vaccinated with the first dose of GARDASIL (lot #not provided).  On an unknown date, "the patient received the second dose of GARDASIL (658554/0928U). * Concomitant suspect therapy included varicella virus vaccine live.  Per the reporter, the patient came back into the office because she was having a cough and cold, which turned out to be prenatal symptoms.  The physician did a pregnancy test on the patient which came back positive.  Per the reporter, the patient received the first dose of varicella virus on 06-DEC-2006.  The lot # for varicella virus vaccine live was 659692/1767U, unspecified which dose.  Additional information received from pregnancy questionnaire (31-MAR-2008):  The lot# for the first dose of GARDASIL was provided as 658094/0524U and the date of the second was listed as 06-FEB-2008.  Follow up information was received which reported that on 16-JUN-2008 the patient delivered a female infant.  The infant's weight was 12.3 (unit not reported), length was 23.25 inches.  The infant was normal, there were no congenital anomalies and no other complications or abnormalities.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Pregnancy test, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse practitioner for the Pregnancy Registry for GARDASIL concerning a 22 year old female who on 27-NOV-2007 was vaccinated with her first dose of GARDASIL (lot # 659437/1266U) and is pregnant.  The patient's LMP was reported as 18-NOV-2007.  The patient had routine prenatal labs.  Subsequently the patient experienced no known symptoms.  Follow-up information was received from a nurse practitioner which reported that the 22 year old female with a history of 2 pregnancies and 1 live birth and a history of cervical intraepithelial neoplasia II-III in 2006, atypical cells of undermined significance (ASCUS)/negative HPV and loop electrosurgical excision procedure (LEEP) and sepsis (February 2006) delivered a normal, healthy male baby weighting 8 pounds on 22-AUG-2008 (weeks from LXP: 39).  On 08-APR-2008.  09-JUN-2008 and 07-AUG-2008 ultrasound indicated there were no anomalies.  On 28-APR-2008, maternal serum alpha-fetoprotein (MSAFP) was negative.  Prenatal vitamins were taken from 22-JAN-2008.  There were no complication during pregnancy and labor/delivery.  There were no infections or illnesses during pregnancy.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Drug exposure during pregnancy, Hydronephrosis, Ultrasound antenatal screen, Ureteric obstruction
Clinical narrative: Information has been received from the Merck Pregnancy Registry for GARDASIL via a medical assistant concerning a 26 year old white female with "kidney problems" who on 08-JAN-2008 was vaccinated IM with a first 0.5ml dose of GARDASIL vaccine (Lot # 659437/1266U) and was " 4 weeks pregnant at the time of the vaccine."  Last menstrual period was approximately 10-DEC-2007.  Estimated date of delivery is 15-SEP-2008.  There were no concomitant medications.  No adverse event occurred.  Laboratory studies performed were "blood work" and an "OB profile" (results not reported).  The patient sought unspecified medical attention.  At the time of the report the outcome was unknown.  Follow-up information was received indicating that on 30-AUG-2008, the patient delivered a normal baby.  During pregnancy, the patient had hydronephrosis and obstructed right ureter.  She also received terbutaline sulfate 2.5 mg every 4 hours on 04-AUG-2008 for contractions.  The patient took prenatal vitamins during pregnancy.  No diagnostic tests during pregnancy.  There were no complications during labor/delivery.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Uterine contractions during pregnancy
Clinical narrative: Information has been received from the Merck Pregnancy Registry for GARDASIL via a medical assistant concerning a 26 year old white female with "kidney problems" who on 08-JAN-2008 was vaccinated IM with a first 0.5ml dose of GARDASIL vaccine (Lot # 659437/1266U) and was " 4 weeks pregnant at the time of the vaccine."  Last menstrual period was approximately 10-DEC-2007.  Estimated date of delivery is 15-SEP-2008.  There were no concomitant medications.  No adverse event occurred.  Laboratory studies performed were "blood work" and an "OB profile" (results not reported).  The patient sought unspecified medical attention.  At the time of the report the outcome was unknown.  Follow-up information was received indicating that on 30-AUG-2008, the patient delivered a normal baby.  During pregnancy, the patient had hydronephrosis and obstructed right ureter.  She also received terbutaline sulfate 2.5 mg every 4 hours on 04-AUG-2008 for contractions.  The patient took prenatal vitamins during pregnancy.  No diagnostic tests during pregnancy.  There were no complications during labor/delivery.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL vaccine (yeast) from a nurse concerning an 18 year old female with pertinent medical history reported as none and no known drug reactions or allergies who on 17-APR-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 657621/0387U) 0.5 ml, IM. The second dose of GARDASIL vaccine (yeast) (lot # 657736/0389U0), 0.5 ml, IM was given on 15-JUN-2007. Concomitant therapy included prenatal vitamins (unspecified) and ferrous sulfate (unspecified). The third dose of GARDASIL vaccine (yeast) (lot # 659055/1522U), 0.5 ml, IM was given on 26-DEC-2007. Subsequently the patient became pregnant. She sought medical attention via an office visit. Her last menstrual period was reported as 29-NOV-2007. Her estimated delivery date was 04-SEP-2008. No adverse event was reported. Follow-up information was received from a licensed practical nurse which reported that on 23-AUG-2008 the patient gave vaginal birth to a live born male weighing 5 lbs. 12.3 oz, APGAR = 9/10. She was 37 weeks from her last menstrual period. The infant was reported to be normal and there were no congenital anomalies or complications. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Medical device complication
Clinical narrative: Information has been received from a health professional concerning a quality issue regarding a pre-filled syringe of GARDASIL (lot # 655327/1287U). It was reported that the syringe's safety mechanism released before it can be given to the patient . No adverse events were reported. Additional information has been requested. The SB# is 1-3060667927.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: Information has been received from a nurse and an office manager concerning an 18 year old female patient, with no known medical history, who on 13-JUN-2008 at 11:30 am was vaccinated intramuscularly with a third dose of GARDASIL vaccine (yeast) (Lot # 659435/1265U), which had been improperly stored. The nurse reported that the vaccine was stored in a refrigerator that had gone below an acceptable range. No adverse events were reported. It is unknown if the patient sought medical attention. No product quality complaint was involved. This is one  of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Medical device complication
Clinical narrative: Information has been received from a medical assistant via the PQC- Product Quality Complaints reporting that a prefilled syringe (size of container: one prefilled syringe) of GARDASIL vaccine (yeast) (lot # 654540/1209U) prematurely activated. The event was considered to be a medical device complication. No adverse event was reported. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: Initial and follow-up information has been received from an office manager concerning a 15 year old female, with no known medical history who on 06-JUN-2008 was vaccinated IM with her first dose of GARDASIL vaccine (yeast) (lot#660553/0070X) which had been improperly stored. The nurse reported that the vaccine was stored in a refrigerator that had gone below an acceptable range. No adverse events reported. It is unknown if the patient sought medical attention. This is one of many reports from the same source. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on 21-JUL-2008 was vaccinated with GARDASIL vaccine (yeast) 0.5 mL IM. Subsequently the patient inadvertently received GARDASIL vaccine (yeast) instead of hepatitis A vaccine and no symptoms were reported. No other information was available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 18-JUL-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot# 658560/1062U) injection. On 18-JUL-2008 the patient left the office, walked out to the parking lot and fainted. Medical attention was sought. There was no additional information provided. At the time of the report the patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse practitioner through the pregnancy registry for GARDASIL vaccine (yeast) concerning an 18 year old female with no medical history and allergic to penicillin, who on 30-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (Lot # 660389/1968U). There was no concomitant medication. On 30-JUL-2008 the patient was found to be pregnant. No problems reported. Date of LMP was 29-JUN-2008. Estimated delivery date is 05-APR-2009. Urine pregnancy test, PAP and STD test (sexually transmitted diseases) were performed. There was no product quality complaint. Follow up information has been received from a nurse practitioner concerning an 18 year old Native American female with a history of 1 previous pregnancy and 1 full term delivery, with no significant past medical history who on 30-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (Lot # 660389/1968U) (Lot # reported as "1968 U"). Concomitant medications included prenatal vitamin daily for pregnancy started on 30-JUL-2008. Birth defect(s) in previous pregnancies and infant complications in previous pregnancies were reported as unknown. Estimated conception date was on 13-JUL-2008. Date of last menstrual period was on 29-JUN-2008 and estimated delivery date is 05-APR-2009. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP, HPV4, MNQ
Symptoms: Activities of daily living impaired, Dizziness, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company. A 10 year old female with no pertinent medical history or drug allergies or drug reactions, who on 04-APR-2008 was vaccinated with GARDASIL vaccine (yeast) intramuscular into the right arm (lot no. 659657/1487U), meningococcal ACYW conj vaccine (dip toxoid) intramuscular into the left arm (lot no. U2543AA), and diphtheria toxoid(+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid intramuscular into the left arm (lot no. AC42B020AA). On 03-APR-2008 the patient received three vaccines, she ran a fever 103 degrees temperature, she complained of dizziness and stayed in bed all day post vaccination. No further information is available. The original reporting source was not provided and considered the events to be non-serious.
Sex: U
Vaccine: HPV4
Symptoms: Medical device complication
Clinical narrative: Information has been received from a woman's clinic regarding GARDASIL in a pre filled syringe. It was reported that the syringe was leaking. No adverse event was reported. In follow up it was reported that the patient received the dose of GARDASIL the same day using a different syringe. The problem was identified before patient was injected so patient never received any of the faulty dose, therefore this reports being deleted from our files, and a healthcare professional did not come into direct contact with the vaccine as a result of the complication. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin negative, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a Caucasian registered nurse for the pregnancy registry for HPV vaccine, concerning a 23 year old female with sulfonamide allergy who on 28-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 660553/0070X, exp: 22-OCT-2010) 0.5ml, intramuscularly. There was no concomitant medication. The nurse reported that the patient received her first dose of HPV vaccine and then discovered that she was pregnant. On 28-JUL-2008, the patient had a urine pregnancy test that was negative, and on 06-AUG-2008 she had another pregnancy test that was positive. The patient's LMP was on 25-JUN-2008 and the EDD is on 01-Apr-2009. No adverse event was reported. The patient sought medical attention at the physician's office. Follow up information was received on 27-AUG-2008 from a registered nurse which reported that the patient's LMP was on 27-JUN-2008. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on 08-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), IM. On 08-AUG-2008, the patient received late the second dose of GARDASIL vaccine (yeast). The patient is not experiencing any known symptoms. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 12 year old female with attention deficit/hyperactivity disorder who on 23-APR-2007, 26-JUN-2007 and 25-OCT-2007 was vaccinated with a first, second and third dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 07-AUG-2008 the patient was vaccinated with a fourth dose of GARDASIL vaccine (yeast) (lot number 0152X) intramuscularly in the right arm and a dose of hepatitis A virus vaccine inactivated (HAVRIX) (lot number AHAVB0233A2) intramuscularly in the left arm. No adverse event was reported. It was unspecified if the patient sought any medical attention. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 20 year old female patient who on 12-MAR-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 27-DEC-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 13-AUG-2008 the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot number 0151X) in the deltoid (injection route not reported). No adverse symptoms. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 year old black student female with no known drug allergies/reactions and no pertinent medical history reported who on 08-SEP-2006 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot# 653937/0637F) in the left deltoid. On 02-NOV-2007, the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (Lot # 657622/0388U) in the right deltoid. On 25-APR-2008, the patient was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot # 659055/1522U) in the left deltoid. On 25-AUG-2008, the patient was vaccinated with an extra dose of GAEDASIL vaccine (yeast) ((lot # 660374/0275X) - invalid) in the left deltoid. No adverse effect reported. This is one of two sibling reports received from the same source. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 42 year old female who on unspecified date, was vaccinated with the first dose of GARDASIL vaccine (yeast). On 21-AUG-2008 was vaccinated the second dose of with GARDASIL vaccine (yeast). No adverse events reported. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients who on an unspecified date was vaccinated with GARDASIL vaccine (yeast) (route and administrating site not reported). Subsequently, the patients experienced pain at the injection site. This one of several reports from the same source. Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in the report were unsuccessful. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Laboratory test, Ultrasound scan
Clinical narrative: Information has been received from a licensed practical for the pregnancy registry for GARDASIL vaccine (yeast) concerning a 27 year old female with no pertinent medical history and no allergies who on 28-DEC-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 659653/1448U). On 28-FEB-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast) (lot # 659655/1486U). On 26-JUN-2008 the patient was vaccinated with the third dose of GARDASIL vaccine (yeast) (lot # 660555/0279X). There was no concomitant medication. The patient became pregnant during the immunization schedule of vaccine. The "ultrascreen and blood test" were performed. The last menstrual period was 16-JUN-2008. The estimated due date is 23-MAR- 2009. Date of conception was three days before receiving the third dose. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Medication error
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on an unspecified date was vaccinated a dose of GARDASIL vaccine (yeast) which was stored improperly. The patient has not experienced any known symptoms. It was unspecified if the patient sought medical attention. This is one of several reports from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Initial and follow-up information has been received from an official concerning unknown number of patients who were vaccinated with GARDASIL vaccine (yeast) at the gluteal region. No symptoms were noted. It was not specified if the patients sought medical attention or not. Attempts are being made to obtain additional identifying information.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 22 year old white female with asthma, rhinitis allergic, gastroesophageal reflux disease and depression who on 06-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number 658556/1060U) in the left deltoid (injection route not reported). Concomitant therapy included (ADVAIR), (NASONEX), (ACIPHEX), (ZOLOFT), (LOESTRIN) and (FERRUM). On 06-JUN-2008, also reported as within six hours after the vaccination, the patient experienced nausea. The physician reported that the patient had emesis four to five times per day for the next two to three days. The patient had no fever, no abdominal pain and no diarrhea. It was unknown whether the patient sought any medical attention. On 10-JUN-2008, the patient recovered from nausea and emesis. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Palpitations, Panic attack
Clinical narrative: Information has been received from a health professional concerning a 23 year old white female who on 29-APR-2008, at 1:56 pm, was vaccinated in the left deltoid with a first dose of GARDASIL vaccine (yeast) (lot #659655/1486U). On the same day the patient experienced panic attack symptoms like heart racing and difficulty breathing. It was reported that the patient called the GARDASIL vaccine (yeast) hotline and no more vaccines were given to the patient. Additional information has been requested. The patient recovered on the saem day. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Panic attack
Clinical narrative: Information has been received from a health professional concerning a 23 year old white female who on 29-APR-2008, at 1:56 pm, was vaccinated in the left deltoid with a first dose of GARDASIL vaccine (yeast) (lot #659655/1486U). On the same day the patient experienced panic attack symptoms like heart racing and difficulty breathing. It was reported that the patient called the GARDASIL vaccine (yeast) hotline and no more vaccines were given to the patient. Additional information has been requested. The patient recovered on the saem day. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Breast feeding
Clinical narrative: Information has been received regarding a case in litigation concerning a 24 year old female with no relevant medical history or allergies who on 25-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Concomitant therapy included vitamins (unspecified). On 27-AUG-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 27-AUG-2008, also reported as starting the day of her second shot of vaccine, the patient experienced hair falling out in handfuls. The patient also reported that she was breastfeeding her 6 month old daughter. The patient's daughter developed a rash on her face. No medical attention was sought. The patient's event persisted. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Information has been received from other health professional concerning a 17 year old Hispanic female with no known medical condition or illness at time of vaccination, who on 19-AUG-2008, at 10:30, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot #659655/1486U) via intramuscular on her right deltoid and varicella virus vaccine live (Oka/Merck) (MSD) via subcutaneous on her left deltoid. On 19-AUG-2008, at 10:30 the patient felt light headed, looked pale and fainted right after shots given. The patient recovered a few seconds after. The patient was monitored for half an hour. The patient stated that she was nervous prior vaccine administration and did not eat in the  morning. Laboratory test were not performed. No further information is available.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Dermatitis, Erythema, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a 35 year old female who on 12-DEC-2007, was vaccinated with her first dose of GARDASIL vaccine (yeast). On 15-FEB-2008, was vaccinated with her second dose of GARDASIL vaccine (yeast). On approximately 29-FEB-2008, two weeks after the second vaccination, the patient experienced dermatitis. The patient reports that when she lightly scratches her skin she gets an erythema that rises up, that she referred to as "Graphic Dermatitis". The patient's "Graphic Dermatitis" was self diagnosed. The patient discussed the dermatitis on her routine office visit on 09-JUL-2008 and a follow-up visit on 06-AUG-2008. The patient's graphic dermatitis persisted. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Fall, Head injury, No reaction on previous exposure to drug, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no known drug reactions/allergies who on an unspecified date was vaccinated with a third dose of GARDASIL vaccine (yeast) (lot# 660620/0571X) IM. There was no concomitant medication. On 29-AUG-2008 the patient fainted, fell and hit her head. The patient was taken to the Emergency Room where she had a computed axial tomography (CT) done. The CT result came back negative. The patient was released. The patient did not faint after the first and second dose. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Somnolence
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who on 09-JUL-2007 was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast), on 10-OCT-2007 was vaccinated intramuscularly with the second dose of GARDASIL vaccine (yeast) and on 30-JAN-2008 was vaccinated intramuscularly with the third dose of GARDASIL vaccine (yeast). On 02-SEP-2008 the patient was vaccinated intramuscularly with the fourth 0.5 ml dose of GARDASIL vaccine (yeast). The patient was sleepy but arousable. At the time of reporting, the outcome was unknown. No product quality complaint was involved. At the time time of reporting, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse (RN) concerning a female who in July 2007, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) and on 02-SEP-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL vaccine (yeast). No problems reported. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Migraine
Clinical narrative: Information has been received from a physician concerning her daughter with a history of migraine in past who on an unspecified date was vaccinated with GARDASIL vaccine (yeast). There was no concomitant medication. The physician's daughter said GARDASIL vaccine (yeast) aggravated her migraine condition. Subsequently, "within a day or two after receiving vaccination", the patient recovered from aggravated her migraine condition. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse, for the Pregnancy Registry for GARDASIL vaccine (yeast), concerning a 15 year old female with no pertinent medical history or drug allergies who at the end of June 2008, was vaccinated with a dose of GARDASIL vaccine (yeast). The nurse did not have lot numbers or number of GARDASIL vaccine (yeast) doses received. There was no concomitant medication. It was reported the patient was pregnant. No adverse effect was reported. The patient sought unspecified medical attention via office visit. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a 24 year old female with no pertinent medical history and no allergies who on 02-FEB-2008 was vaccinated with the first dose of GARDASIL IM 0.5ml. On 07-MAR-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5ml. On 07-AUG-2008 (reported as 08/07/2007) the patient was vaccinated with the third dose of GARDASIL IM 0.5ml. There was no concomitant medication. On 25-APR-2008 the patient experienced severe joint pain after receiving her second dose. The patient's severe joint pain persisted. The patient sought medical attention. Additional information has been requested.  2/20/09 Received PCP medical records of 10/1/08-12/29/08. FINAL DX: none provided Records reveal patient experienced back pain, left paraspinal muscle spasms & bilateral hip pain.  Tx w/meds, PT & referred for MRI.
Sex: F
Vaccine: HPV4
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a practice manager concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). Subsequently the patient experienced hives at the injection site. It was unknown whether the patient sought any medical attention. The outcome was unspecified. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a female who in approximately May 2008, also reported as four months ago, was vaccinated with a first 0.5 ml dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). The patient reported that she would be getting her second dose soon. The patient did not have ill effects from this. No further information is available
Sex: F
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: Information has been received from a office manager concerning a female who in June 2007, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 02-SEP-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). No adverse effect reported. Unspecified medical attention was sought. Additional information has been requested.