chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Eye swelling, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old patient who on 25-MAR-2008 was vaccinated PO with the third dose of Rotateq (lot# not available).  On that same day the patient developed a rash, swollen eyes and experienced diarrhea.  The patient sought medical attention through an office visit.  The rash was worse the next day.  The infant was treated with BENADRYL.  On 27-MAR-2008 the infant's eyes were no longer swollen and the rash improved.  The patient was noted to be recovering from the rash and the outcome was unknown for diarrhea.  Dates of administration for the first and second doses of Rotateq (lot numbers not available) were not available.  There was no product quality complaint.  Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a male who on 07-MAR-2008 was vaccinated PO with the first and second (lot# 659856/1731U) 2.0 ml doses of Rotateq.  The reporting nurse thought they were administering dose 1 and did not realize the patient received a previous dose earlier in the month at a different facility.  At this point the nurse was not aware of any symptoms.  There was no product quality complaint.  Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse concerning a male who was vaccinated with the first and second doses of ROTATEQ.  Subsequently the patient threw up at home following the first dose.  Subsequently, the patient recovered.  After the second dose, the patient threw up.  The outcome was unknown.  Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 week old patient who on 25-MAR-2008 was inadvertently vaccinated with the first dose of ROTATEQ. No adverse symptoms were noted. This was not a product quality concern. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with the second dose of Rotateq.  Subsequently the patient experienced diarrhea.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated PO with the first 2.0 ml dose of ROTATEQ.  Subsequently the patient experienced a rotavirus infection.  The patient sought medical attention through an ER visit.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 0.96
Sex: F
Vaccine: DTAP, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated with the third dose (completed series) of Rotateq after the age of 12 months.  No symptoms were reported.  There was no product quality complaint.  Additional information has been requested.  This is one of several reports from the same source. This is in follow-up to report(s) previously submitted on 4/14/2009.   Follow-up information from the reporting administering physician indicated that the 11 month old female with no pre-existing medical conditions or allergies who on 04-FEB-2008 at 11:00 was vaccinated PO with her first dose of ROTATEQ (lot# 657665/1460U).  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day at 11:00 included the third IM dose of DAPTACEL (lot# C2797AA).  No adverse event was noted.  No medical attention was sought.  On 28-APR-2008 the baby was seen by the physician with no history of side effects.  Additional information has been requested.  This is one of several reports from the same source.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning an infant who was vaccinated with the third dose (completed series) of ROTATEQ after the age of 12 months. No symptoms were reported. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rash, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 week old female with no pre-existing medical history of allergies who on 27-NOV-2007 at 11:00 and on 29-JAN-2008 at 14:15 was vaccinated PO with her first and second doses of Rotateq (lot# 657671/0902U, 657986/1205U).  There was no illness at the time of vaccination.  On 27-NOV-2007 beginning the same day of the first vaccination, the patient experienced severe diarrhea, vomiting and rash.  The patient did not seek medical attention.  No labs or diagnostic tests were performed.  Subsequently the patient recovered (date unknown).  On 29-JAN-2008 beginning the same day of the second vaccination, the patient experienced severe diarrhea, vomiting and rash.  Subsequently, the patient recovered (date unknown).  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram, Convulsion, Lumbar puncture
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 week old female with no pertinent medical history or drug allergies who on 20-MAR-2008 was vaccinated PO with her first dose of ROTATEQ (lot# 659917/0017X).  Concomitant vaccinations administered on that same day included a dose of PEDIARIX, a dose of PREVNAR and a dose of ACTHIB.  On that same day the patient experienced seizure-like activity for 1 & 1/2 minutes.  "The patient was sent to the emergency and was admitted to the hospital overnight."  Lab diagnostic studies included a "CAT scan and LP."  Subsequently, the patient recovered.  There was no product quality complaint.  No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning her infant granddaughter who was recently vaccinated with a dose of ROTATEQ. Subsequently the patient experienced diarrhea. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on approximately 03-MAR-2008 3-4 weeks ago, was vaccinated PO with his first 2.0 ml dose of Rotateq.  On approximately 10-MAR-2008 a week after vaccination, the patient experienced diarrhea.  The infant was seen in the office twice for the same symptom.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Antibody test, Cough, Herpes zoster, Rash papular, Respiratory tract congestion
Clinical narrative: Information has been received from a physician concerning a 4 year old male who on 23-JAN-2004 and 29-JAN-2007 was vaccinated with his first and second doses of Varivax (Oka/Merck).  On 11-DEC-2007 the patient developed shingles which was described as a unilateral dermatome on the right side of the abdomen with crusted clusters of papules that stopped at the midline.  It was unspecified whether medical attention was sought.  Subsequently, the patient recovered.  There was no product quality complaint.  Follow-up information from the reporting physician indicated that the 5 year old male with no history or recent exposure of chickenpox was on 29-JAN-2007 at 10:00 was vaccinated with his first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655838/1262F) in the left arm.  On 11-DEC-2007 the patient developed shingles with other symptoms of cough and congestion.  It was noted that on 23-JAN-2004 at 10:00 the patient was vaccinated with his first dose of Varivax (Oka/Merck) (lot# 644558/1156M) in the left arm.  There was no sign of fever and no rash occurred.  The patient had clusters of papules some crusted, located on the right back/side of the abdomen.  A specimen was not collected for PCR, no photos were taken and a direct fluorescent antibody test was performed.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Scab
Clinical narrative: Information has been received from a physician concerning a 4 year old male who on 23-JAN-2004 and 29-JAN-2007 was vaccinated with his first and second doses of Varivax (Oka/Merck).  On 11-DEC-2007 the patient developed shingles which was described as a unilateral dermatome on the right side of the abdomen with crusted clusters of papules that stopped at the midline.  It was unspecified whether medical attention was sought.  Subsequently, the patient recovered.  There was no product quality complaint.  Follow-up information from the reporting physician indicated that the 5 year old male with no history or recent exposure of chickenpox was on 29-JAN-2007 at 10:00 was vaccinated with his first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655838/1262F) in the left arm.  On 11-DEC-2007 the patient developed shingles with other symptoms of cough and congestion.  It was noted that on 23-JAN-2004 at 10:00 the patient was vaccinated with his first dose of Varivax (Oka/Merck) (lot# 644558/1156M) in the left arm.  There was no sign of fever and no rash occurred.  The patient had clusters of papules some crusted, located on the right back/side of the abdomen.  A specimen was not collected for PCR, no photos were taken and a direct fluorescent antibody test was performed.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion threatened, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan
Clinical narrative: Information has been received from a physician as part of the Merck Pregnancy registry concerning a 25 year old white female patient with no past medical history who on 28-MAR-2007 was vaccinated with a first dose of GARDASIL (lot # 655126/0087U). A second dose was given on 29-MAR-2007 (lot # 0211U). There was no concomitant medication. The patient's LMP was 31-AUG-2007. The patient is now pregnant. She had a home pregnancy test and an ultrasound. She had an ultrasound on 24-OCT-2007 for a threatened miscarriage which was within limits and an MSAFP test on 02-JAN-2008 for a screening which was negative. On 07-NOV-2007 she started unspecified prenatal medications. There were no problems reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Laboratory test, Menstruation irregular
Clinical narrative: Information has been received from a health professional as part of the Merck Pregnancy Registry concerning a 19 year old female with a history of an elective termination who on 05-JUL-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil.  She received the second dose on 01-NOV-2007.  Concomitant therapy included fluoxetine.  On 05-OCT-2007 the patient had "hormone levels" due to irregular periods and a negative HCG level.  On 11-DEC-2007 the patient had a positive HCG level.  On 03-JAN-208 the patient experienced abdominal pain and had an ultrasound which showed healthy intrauterine pregnancy 11 weeks, 6 days.  Additional information has been requested. Informatoin has been received froma nurse practitioner, for the Pregnancy Registry for GARDASIL concerning a 19 year old female with a history of one previous spontaneous abortion and sinusitis who on 05-JUL-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL. She received the second dose on 01-NOV-2007. On 05-OCT-2007 the patient had "hormone levels" due to irregular periods and a negative HCG level. On 11-DEC-2007 the patient had a positive HCG level. On 03-JAN-2008 the patient experienced abdominal pain and had an ultrasound which showed healthy intrauterine pregnancy 11 weeks, 6 days. Follow-up information was received. On 14-JUL-2008 the patient delivereda normal, healthy male baby weighing 8 pounds and 2 oz. The baby was 21 inch. There was no congenital anomalies, complications or abnormalities. There were also no complications during the pregnancy or during labor/delivery. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Sinusitis, Ultrasound abdomen normal
Clinical narrative: Information has been received from a health professional as part of the Merck Pregnancy Registry concerning a 19 year old female with a history of an elective termination who on 05-JUL-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil.  She received the second dose on 01-NOV-2007.  Concomitant therapy included fluoxetine.  On 05-OCT-2007 the patient had "hormone levels" due to irregular periods and a negative HCG level.  On 11-DEC-2007 the patient had a positive HCG level.  On 03-JAN-208 the patient experienced abdominal pain and had an ultrasound which showed healthy intrauterine pregnancy 11 weeks, 6 days.  Additional information has been requested. Informatoin has been received froma nurse practitioner, for the Pregnancy Registry for GARDASIL concerning a 19 year old female with a history of one previous spontaneous abortion and sinusitis who on 05-JUL-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL. She received the second dose on 01-NOV-2007. On 05-OCT-2007 the patient had "hormone levels" due to irregular periods and a negative HCG level. On 11-DEC-2007 the patient had a positive HCG level. On 03-JAN-2008 the patient experienced abdominal pain and had an ultrasound which showed healthy intrauterine pregnancy 11 weeks, 6 days. Follow-up information was received. On 14-JUL-2008 the patient delivereda normal, healthy male baby weighing 8 pounds and 2 oz. The baby was 21 inch. There was no congenital anomalies, complications or abnormalities. There were also no complications during the pregnancy or during labor/delivery. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein abnormal, Beta haemolytic streptococcal infection, Blood human chorionic gonadotropin negative, Drug exposure during pregnancy
Clinical narrative: Initial and follow-up information has been received through the pregnancy registry from a certified medical assistant concerning a 17 year old black female with asthma, who on 09-MAY-2007 was vaccinated with GARDASIL.  Concomitant suspect therapies included montelukast sodium (SINGULAIR).  Concomitant therapies included fluticasone propionate (+) salmeterol xinafoate (ADVAIR).  The patient was vaccinated while was pregnant.  Patient sought unspecified medical attention and had a positive pregnancy test.  On 11-APR-2007 a routine test for Cystic fibrosis was performed and was negative.  On 12-APR-2007 a routine test for hemoglobin solubility was performed and was negative.  On 23-MAY-2007 a serum alpha-fetoprotein test was performed and was negative.  On 11-SEP-2007 an ultrasound was performed for Oligohydramios and was normal.  The patient's last menstrual period was 29-JAN-2007 with an estimated date of delivery of 05-NOV-2007.  There were no symptoms reported.  Follow-up indicated that on 08-NOV-2007 the patient gave birth to a liveborn female infant.  The infant weighed 2778 grams and her apgar score was 8/9.  It was reported that the baby was born healthy and with no congenital anomalies.  The patient gave birth "40+" weeks from her last menstrual period.  There were no complications during pregnancy, no complications during labor/delivery, and no infections or illnesses during pregnancy.  During the delivery an episiotomy was performed.  It was reported that the patient had one full term delivery and no birth defects or infant complications in previous pregnancies.  The physician reported that "as far as she knew the baby was normal and healthy."  The patient tested positive for Group B streptococcus and was treated.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Vaginitis bacterial
Clinical narrative: Information has been received from a Registered Nurse concerning a black 17 year old female who on 22-MAR-2007 was vaccinated, IM 0.5mL, first dose, with GARDASIL (lot# 655619/1427F). Subsequently the patient was determined to be pregnant. The patient sought unspecified medical attention. No problems were reported. Follow-up information received on 11-FEB-2008 reported that a nurse in the office stated that the patient has delivered her baby and both Mom and baby were doing fine. She also reported that the Doctor apologizes that she keeps forgetting to have the patient sign the consent forms. She will try to remember when the patient is seen again. Follow up information received on 31-MAR-2008 reported that the patient, who had a history of migraines and no previous pregnancies delivered a normal female infant on 27-SEP-2007 (40 weeks from LMP) (weight: 7 pounds 6 ounces, length 53.5 cm, Apgar score 8/9, head circumference 33). No congenital anomalies or complications were reported. At 35 weeks gestation (on approximately 24-AUG-2007), the mother developed bacterial vaginosis and was treated with FLAGYL. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy induced hypertension, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse through the Pregnancy Registry for Gardasil concerning a 27 year old female, with a history of two previous pregnancies (one live birth and one spontaneous abortion), who on 19-FEB-2007 was vaccinated in the right deltoid with her first dose of Gardasil.  On 12-APR-2007, the patient was vaccinated in the left deltoid with her second dose of Gardasil (Lot #656051/0244U).  On 10-OCT-2007 it was reported that the patient had a urine test (date unspecified) which was positive (LMP 14-MAY-2007).  The patient sought unspecified medical attention at an office visit.  Follow-up information received 27-MAR-2008, reports that the patient was on prenatal vitamins (unspecified), and developed pregnancy induced hypertension (not further specified).  The patient had routine diagnostic tests (not further specified).  On 13-FEB-2008, the patient delivered a live, normal, 8 pound, male infant (length not reported).  There were no complications during labor or delivery, no congenital anomalies, or complications.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 26 year old female who was vaccinated on an unspecified date with her first dose of GARDASIL (lot# not reported).  Subsequently the patient experienced urticaria 34 hours after administration of the vaccine.  Subsequently, the patient recovered from urticaria within 1 day after receiving 1 dose of loratadine (CLARITIN).  The patient sought medical attention via the telephone.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 07-MAR-2008 was vaccinated with GARADASIL (lot# not reported). On 09-MAR-2008 the patient fainted. The patient's outcome was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who in approximately February 2008, was vaccinated with the first dose of GARDASIL (lot# not provided).  The same night following vaccination, the patient went to the Emergency Room with a swollen and painful arm.  No further information was provided.  Additional information has been requested. Additional information received from D-form (07/APR-2008). For the reporter, the patient received her first dose of GARDASIL and within 48 hours experienced pain, swelling and redness of arm, resulting in an ER visit. The patient was treated with oral steroids. Subsequently, the patient recovered from the pain, swelling and redness of her arm. The reporter did not see the patient during the acute reaction, but was informed after recovery. There is no additional information. Additional information received from D-form (29-APR-2008). The patient is an otherwise healthy 11-year-old female with a history of chicken pox disease as a younger child. On 19-MAR-2008 the patient was vaccinated in the left arm with the first dose of GARDASIL (lot# 657621/0387U). On 12-APR-2008 the patient developed Herpes Zoster on the skin of her left back/side/chest. The patient twice sought unspecified medical attention in the physician's office. VALTREX was initiated on 18-APR-2008. The patient is currently recovering. The physician is not sure if the Herpes Zoster was related to GARDASIL vaccine. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Gaze palsy, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 28-FEB-2008 was vaccinated with the first dose of GARDASIL (lot reported as "0724U"). Concomitant suspect therapy included VARIVAX (Oka/Merck) (MSD). Other concomitant therapy included MENACTRA (Sanofi Pasteur), hepatitis A virus vaccine (unspecified) and tuberculin purified protein derivative. Per the reporter, after receiving the first dose of GARDASIL, the patient's eyes instantly rolled into the back of her head and she fainted. The patient was "administered alcohol" and she recovered. No additional information was provided regarding this adverse experience. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting in pregnancy
Clinical narrative: Information has been received from a nurse concerning a 15 year old female with anxiety who on 03-JAN-2008 was vaccinated intramuscularly with her third dose of GARDASIL (lot# not provided).  On 04-JAN-2008 the patient started experiencing morning sickness.  The patient's morning sickness persisted.  She sought unspecified medical attention.  The patient did not have any AE after the 1st or 2nd dose of GARDASIL.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who approximately "within two weeks" was vaccinated with the third dose of GARDASIL.  The patient fainted after getting the third dose of GARDASIL (lot number not provided).  No information about first and second dose.  Unknown medical attention was sought.  On a unspecified date the patient outcome was recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal pain upper, Drug exposure during pregnancy, Pain in extremity
Clinical narrative: Information has been received from a 19 year old female for the Pregnancy Registry for GARDASIL with a history of miscarriage who on 31-JUL-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# not reported). On 03-MAR-2008 the patient was vaccinated intramuscularly with her third dose of GARDASIL (lot# not reported). Concomitant therapy included hepatitis A virus vaccine (unspecified). On 07-MAR-2008 the patient found out she was pregnant. Her LMP was 06-FEB-2008. The patient also stated that she was experiencing pain from her stomach to her knees. The pain goes away when she stays in bed, but comes back when she walks around. She did not think the pain was caused from the pregnancy. The patient's outcome was not reported. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Hepatomegaly
Clinical narrative: Information has been received from a physician concerning a female friend of a patient's mother who was vaccinated with GARDASIL (dose, route, site and Lot # not reported).  Subsequently the patient experienced enlarged liver after vaccination.  Patient outcome was not reported.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 year old female who was vaccinated on an unspecified date with her first dose of Gardasil (lot# not reported).  Concomitant therapy included Varivax (duration and dose not reported).  Other concomitant therapy included MENACTRA and Tdap.  Subsequently the patient broke out into hives, became dizzy and started to sweat after receiving Gardasil.  The patient was recovering.  She sought unspecified medical attention.  Additional information has been requested. Additional information was received. The nurse indicated that without a patient's name she can not fill out the form. She was advised to call the MNSC, but they could not provide the patient's name.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 28-NOV-2007 was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (lot # 658556/1060U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 19-FEB-2008 the patient was vaccinated intramuscularly in the left arm with her second dose of GARDASIL (lot# not reported).  While in the office, the patient experienced soreness down her arm to her fingers and intermittent numbness in her hand all in the left arm. The patient used ibuprofen (MOTRIN) intermittently and was offered physical therapy, but declined. The patient recovered after 6 weeks. The patient sought medical attention in the office. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated intramuscularly on an unspecified date with Gardasil (lot# not reported).  Subsequently the patient experienced anxiety after receiving the vaccine.  The patient sought unspecified medical attention and her outcome was not reported.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Information has been received from a physician concerning a 13 year old female with an allergy to Amoxil, who was vaccinated intramuscularly in the right arm on 18-Oct-2007 with Gardasil (lot# 658556/1060U).  Concomitant medication included the influenza virus vaccine (unspecified) which was administered in her left arm on 18-Oct-2007 (lot Number U2443AA).  Subsequently the patient experienced numbness in her arm for one to three months post vaccination.  The patient sought unspecified medical attention.  Follow up information revealed the pain is still lingering at the time of second dose, which is 2 months later.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Pain
Clinical narrative: Information has been received from a health professional concerning a 31 year old female who on 12-SEP-2007 was vaccinated with the first dose of GARDASIL.  On 12-Nov-2007, the patient received the second dose and on 11-Mar-2008 received the third dose IM (lot# 659182/1757U).  After the third dose the patient experienced "a little more soreness than usual".  It was unknown whether patient experienced any problems with first and second dose.  The patient was seen in the doctor's office.  At the time of report the patient had not recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 15 year old female who was vaccinated with the second dose GARDASIL (lot# not provided). Subsequently the patient experienced fainted. It was unknown whether medical attention was sought. The patient's outcome is known. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Information has been received from a Nurse concerning a female patient who on 11-MAR-2008 was vaccinated IM with the first dose of GARDASIL (lot# not provided).  Thirty minutes later the patient passed out and fell on her face.  Unknown medical attention was sought.  At the time of reporting the patient was recovering.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Fall, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: Information has been received from medical assistant concerning a 13 year old female patient who on 11-MAR-2008 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot# 655604/0052X). Concomitant therapy included MENACTRA. On 11-MAR-2008, after receiving the dose the patient was waiting on the table when 30 seconds later she landed backward on the table in which her eyes rolled back, she stiffened and jerked for 3 seconds. Patient stayed extra 15 minutes then went home. The patient was recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in April 2007, was vaccinated with the series of GARDASIL. She had two doses. Subsequently the patient experienced migraines after the doses and they had continued. It was unknown whether medical attention was sought. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 21 year old female patient who on an unspecified date was vaccinated with a 0.5 ml second dose of Gardasil (lot# not provided).  Subsequently the patient experienced mild hives. No respiratory problems. The patient did not have any AE symptoms with the first vaccination.  Unknown medical attention was sought.  At an unspecified date the patient's hives faded without further incident.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with the second dose of GARDASIL (lot# not reported).  Subsequently the patient experienced dizziness and nausea one month after receiving the second dose.  The patient sought unspecified medical attention.  The patient did not have any side effects after receiving the first dose.  Additional information received 28-MAR-2008.  The nurse called to state that the practice does not have any further information regarding the case and they do not want to receive any further letters.  Additional information is not expected. Additional information received from memo (01-APR-2008): Nurse states, "No further information." Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning 2 patients who were vaccinated with Gardasil (lot# not reported).  Per the reporter, both patients experienced syncope after receiving the Gardasil.  The patients sought unspecified medical attention.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Biopsy cervix, Drug exposure during pregnancy, Pregnancy test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer through the Merck pregnancy registry concerning a 16 year old female who on 01-FEB-2008 was vaccinated with the third dose of GARDASIL (lot# not reported). Concomitant suspect therapy included VARIVAX (Oka/MSD) (MSD) (lot# not reported). Other concomitant medication included VENTILAN (albuterol) and prenatal vitamins. Per the reporter, the patient found out that she was pregnant about a week after receiving the third dose. Before she was known to be pregnant, the patient had a pap smear that was irregular, so a biopsy of the cervix was performed. Per the reporter, "I don't know if this made her more fertile. Also, before her pregnancy, when she received her first dose, she experienced an irregular menstrual cycle." The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil (lot# not reported).  Per the reporter, the patient fainted but recovered quickly.  The physician stated "it wasn't like real syncope."  The patient sought unspecified medical attention in the physician's office.  No further information was provided.  The physician did not wish to be contacted.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Juvenile arthritis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with the first dose of GARDASIL (lot# not reported).  Subsequently the patient experienced arthralgia.  Per the reporter, the patient was diagnosed with juvenile rheumatoid arthritis.  The patient's rheumatologist recommended that she not continue the series.  No additional information was given.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy, Cryotherapy, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 20 year old female who was a previous smoker and took birth control pills in the past, who on 21-FEB-2007 was IM vaccinated with her first dose of GARDASIL (lot number unspecified).  On 25-Apr-2007 she was IM vaccinated with her second dose of GARDASIL (lot number unspecified).  On 25-Aug-2007 the patient received her third dose of GARDASIL (lot number unspecified) intramuscularly.  Concomitant therapy included hormonal contraceptives (unspecified) in the past.  A pap test on 07-Feb-2007 was negative.  A repeat PAP test on 07-Aug-2007 was positive for low grade dysplasia CIN 1.  She was also HPV positive for one of the high risk groups.  Colposcopy on 06-Sep-2007 confirmed CIN 1.  The patient had Cryotherapy on 27-Sep-2007.  A pap in February 2008 still shows low grade dysplasia.  The patient sought medical treatment with an office visit.  The patient has not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pelvic pain
Clinical narrative: Information has been received from a health professional concerning a female who was IM vaccinated with her first dose of Gardasil (lot number unspecified) and experienced a mild unspecified pain.  The patient received her second dose of Gardasil (lot number unspecified) intramuscularly and experienced a more severe pain in her pelvic area which intensified when she walked.  The caller was not able to provide the lots numbers for the vaccinations.  The patient sought medical care by calling the office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: Information has been received from a company representative concerning a female who on unspecified date was vaccinated with Gardasil (lot# unspecified) and experienced muscle soreness all over her body.  Unspecified medical attention was sought.  At the time of this report the outcome was unknown.  No other information was provided.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Mouth injury, Suture insertion, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on approximately 11-FEB-2008 was vaccinated with her second dose of GARDASIL (lot# not reported) and fainted. The patient had not eaten anything yet. Sometime later at home, patient fainted again and bit her lip. She went to the Emergency Room for stitches. Her outcome was not reported. Additional information has been requested. A coding change request was made - lip injury.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a health professional concerning a 20 year old female who was vaccinated on an unspecified date with Gardasil (lot# not reported) and felt lightheaded.  The patient recovered after sitting in the office for few minutes.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a health professional concerning a 20 year old female who was vaccinated in 2007 with her first dose of GARDASIL (lot# not reported) and felt lightheaded. The patient recovered after sitting in the office for a few minutes. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with no medical history or allergies reported, who on 19-FEB-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot #659657/1487U). Concomitant therapy included TRI-CYCLEN LO. On 20-FEB-2008 the patient developed a rash described as itchy, diffuse plaque on her neck, back and lower abdomen. The patient was seen at the clinic and treated with BENADRYL. No diagnostic studies were performed. At the time of the report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a physician concerning a female who in November 2007, was vaccinated with the third dose of Gardasil.  On 12-MAR-2008 the patient was seen in the office and has genital warts.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discomfort, Nasopharyngitis, Throat irritation
Clinical narrative: Information has been received from a physician concerning a 25 year old female with a history of cardiac murmur who in January 2008, was vaccinated with her first dose of GARDASIL (lot number unspecified).  Concomitant therapy included fexofenadine hydrochloride (ALLEGRA) and hormonal contraceptives (unspecified).  In January 2008, after receiving the vaccine, the patient experienced uncomfortable feeling on the injection site.  On 10-Mar-2008, the patient experienced scratchy throat and cold after a flight.  Patient still has the cold and scratchy throat. Additional information has been requested. Follow up information received from the physician indicated the patient never mentioned the adverse events. During the patient's visit in March 2008, the patient did not report any of those experiences with second injection.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Nausea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 30-AUG-2007 was vaccinated with her first dose of GARDASIL (lot number reported as "14267F"). Concomitant therapy included VARIVAX, VAQTA and MENACTRA. On 30-AUG-2007 the patient experienced nausea and vomiting which lasted for 2 days. On 18-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (lot number 659439/1267U) and she experienced nausea and vomiting which lasted for 2 days. Additional information has been requested.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Autoimmune disorder
Clinical narrative: Information has been received from a consumer concerning his daughter who was vaccinated with all three doses of Gardasil on unspecified dates (lot #'s not provided).  Concomitant therapy included influenza virus vaccine (unspecified).  On approximately 01-MAR-2008 the patient experienced an autoimmune disease after receiving the influenza virus vaccine and Gardasil.  The patient's autoimmune disease persisted and she sought unspecified medical attention.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Initial information and follow up has been received from a health professional concerning a 16 year old female with metabolic syndrome, reflux nephropathy and Gitelman's syndrome who on 17-MAR-2008 was vaccinated with her first dose of Gardasil (lot# 655327/1287U).  Concomitant therapy included K-LOR, Mg oxide, DYRENIUM, CEFTIN and ORTHO TRI-CYCLEN LO.  On 17-MAR-2008 the patient experienced soreness in her injection arm.  On 21-MAR-2008 the patient's upper arm became swollen and on 22-MAR-2008 the swelling spread to her fingertips.  The patient was seen in the ER and is recovering on an unspecified date.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: HIV test false positive, HIV test negative
Clinical narrative: Information has been received from a physician assistant concerning a 21 year old female who on 25-NOV-2007 was vaccinated with a dose of GARDASIL and on 22-JAN-2008 was vaccinated with a dose of GARDASIL.  There was no concomitant medication.  On 11-MAR-2008 false positive on a HIV test.  An HIV test was done on 11-MAR-2008 that was positive which mandates an automatic confirmation test to be done that same day which was negative.  The confirmation test is more in depth and accurate so the patient was not HIV positive.  Medical attention was sought in the office.  Patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary pain, Injection site bruising, Injection site mass, Injection site pain, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 21-MAR-2008 was vaccinated intramuscularly "probably in the left arm" with her second dose of GARDASIL. On 24-MAR-2008 the patient called the doctor's office complaining of bruises and lump at the injection site and pain from her shoulder to armpit. The patient's bruises and lump at the injection site and pain from shoulder to armpit persisted. The patient did not experience any adverse effects after the first dose of GARDASIL. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Information and follow up has been received from a physician concerning a 20 year old female who on 21-MAR-2008 was vaccinated intramuscularly "probably in the left arm" with her second dose of GARDASIL (lot# 0151X). On 24-MAR-2008 the patient called the doctor's office complaining of bruises and lump at the injection site and pain from her shoulder to armpit. The patient's bruises and lump at the injection site and pain from shoulder to armpit persisted. The patient did not experience any adverse effects after the first dose of GARDASIL. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 21-MAR-2008 was vaccinated intramuscularly "probably in the left arm" with her second dose of GARDASIL. On 24-MAR-2008 the patient called the doctor's office complaining of bruises and lump at the injection site and pain from her shoulder to armpit. The patient's bruises and lump at the injection site and pain from shoulder to armpit persisted. The patient did not experience any adverse effects after the first dose of GARDASIL. Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/14/2008. Information and follow up has been received from a physician concerning a 20 year old female who on 21-MAR-2008 was vaccinated intramuscularly "probably in the left arm" with her second dose of GARDASIL (lot# 0151X). On 24-MAR-2008 the patient called the doctor's office complaining of bruises and lump at the injection site and pain from her shoulder to armpit. The patient's bruises and lump at the injection site and pain from shoulder to armpit persisted. The patient did not experience any adverse effects after the first dose of GARDASIL. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site bruising, Injection site discolouration, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 01-OCT-2007 was vaccinated with her first dose of Gardasil (lot# 0530U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 01-OCT-2007 the patient experienced pain, bruising and a lump at the injection site.  Subsequently, the patient recovered from pain, bruising and a lump at the injection site.  On 10-DEC-2007 the patient was vaccinated with her second dose of Gardasil (lot# 655154/1210U).  On approximately 31-DEC-2007 the patient developed a [[name]] ring, with a small [[name]] center at the injection site.  The patient's [[name]] ring, with a small [[name]] center at the injection site persisted.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin exfoliation, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a female with a latex allergy, penicillin allergy, augmentin allergy, amoxicillin allergy and prednisone allergy who on 01-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 657737/0522U). Concomitant therapy included and eczema drug. On approximately 01-AUG-2007 the patient experienced redness and warmth at the injection site. On 20-DEC-2007 the patient was vaccinated intramuscularly with her second dose GARDASIL (lot# 658488/1264U). On approximately 20-DEC-2007 the patient experienced redness and warmth at the injection site and peeling of the skin in a 3 inch area at the injection site. Subsequently, the patient recovered from redness and warmth at the injection site, and peeling of the skin at the injection site. Additional information has been requested. 02/17/2010 Subsequently, the patient recovered from redness and warmth at the injection site, and swelling of the skin at the injection site.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no medical history and no drug allergies, who on 12-MAR-2008 was vaccinated IM in the deltoid (unspecified which deltoid) with a 0.5mL first dose of Gardasil (Lot# 659962/1740U).  Concomitant vaccination included Tdap.  On 12-MAR-2008 the patient experienced dizziness and nausea when she turned her head.  The patient spoke to the office on 20-MAR-2008.  The patient reported that the dizziness was ongoing.  The patient went to the emergency room.  The patient was not hospitalized and the emergency room could not determine a diagnosis.  At the time of the report, the patient was not recovered.  No product quality complaint was involved.  Additional information has been requested.